Device Registration and Listings

  • 0 ::
      • Pma_number :
        • Proprietary_name ::
            • 0 : Pulmonary Rehabilitation Pack
          • Products ::
              • 0 ::
                  • Created_date : 2010-01-13
                    • Product_code : OGW
                      • Openfda ::
                          • Regulation_number : 868.5800
                            • Medical_specialty_description : Anesthesiology
                              • Device_class : 2
                                • Device_name : Tracheostomy Kit
                              • Owner_operator_number : 8032044
                                • Exempt :
                          • K_number :
                            • Establishment_type ::
                                • 0 : Manufacture Medical Device
                                  • 1 : Repack or Relabel Medical Device
                                • Registration ::
                                    • Iso_country_code : US
                                      • City : New Berlin
                                        • Initial_importer_flag : Y
                                          • Name : ATOS MEDICAL, INC.
                                            • Status_code : 1
                                              • Zip_code : 53151
                                                • Fei_number : 3007501574
                                                  • Postal_code :
                                                    • Reg_expiry_date_year : 2018
                                                      • Owner_operator ::
                                                          • Contact_address ::
                                                              • Iso_country_code : SE
                                                                • City : HORBY
                                                                  • State_province :
                                                                    • Postal_code : SE-24222
                                                                      • Address_1 : KRAFTGATAN 8
                                                                        • Address_2 : --
                                                                          • State_code : SE-NOTA
                                                                        • Owner_operator_number : 8032044
                                                                          • Official_correspondent ::
                                                                            • Firm_name : ATOS MEDICAL AB
                                                                          • Us_agent ::
                                                                            • State_code : WI
                                                                              • Address_line_2 :
                                                                                • Registration_number : 2135136
                                                                                  • Address_line_1 : 2801 S Moorland Rd

      Device Registration and Listings

      • 1 ::
          • Pma_number :
            • Proprietary_name ::
              • Products ::
                  • 0 ::
                      • Created_date : 2014-03-03
                        • Product_code : EJF
                          • Openfda ::
                              • Regulation_number : 872.5410
                                • Medical_specialty_description : Dental
                                  • Device_class : 1
                                    • Device_name : Bracket, Metal, Orthodontic
                                  • Owner_operator_number : 10030849
                                    • Exempt :
                              • K_number :
                                • Establishment_type ::
                                    • 0 : Manufacture Medical Device
                                  • Registration ::
                                      • Iso_country_code : DE
                                        • City : Karlsruhe Baden-Wurttemberg
                                          • Initial_importer_flag : N
                                            • Name : TRINON TITANIUM GMBH
                                              • Status_code : 1
                                                • Zip_code :
                                                  • Fei_number : 3007636114
                                                    • Postal_code : 76137
                                                      • Reg_expiry_date_year : 2018
                                                        • Owner_operator ::
                                                            • Contact_address ::
                                                                • Iso_country_code : DE
                                                                  • City : Karlsruhe
                                                                    • State_province : Baden-Wurttemberg
                                                                      • Postal_code : 76137
                                                                        • Address_1 : Augartenstr. 1
                                                                          • Address_2 :
                                                                            • State_code : DE-BW
                                                                          • Owner_operator_number : 10030849
                                                                            • Official_correspondent ::
                                                                                • Middle_initial :
                                                                                  • Subaccount_company_name :
                                                                                    • First_name : Ekatarina
                                                                                      • Last_name : Lvova
                                                                                        • Phone_number : 49-721-9327-00
                                                                                      • Firm_name : TRINON Titanium GmbH
                                                                                    • Us_agent ::
                                                                                        • Iso_country_code : US
                                                                                          • City : Portsmouth
                                                                                            • State_code : NH
                                                                                              • Bus_phone_area_code : 603
                                                                                                • Name : Franz Menean
                                                                                                  • Address_line_2 :
                                                                                                    • Fax_area_code : 603
                                                                                                      • Bus_phone_extn :
                                                                                                        • Address_line_1 : 112 CORPORATE DR
                                                                                                          • Postal_code :
                                                                                                            • Fax_num : 5702055
                                                                                                              • Business_name : MEDAGENT, Inc.
                                                                                                                • Bus_phone_num : 5702039
                                                                                                                  • Email_address : mail@medagent-usa.com
                                                                                                                    • Zip_code : 03801
                                                                                                                  • State_code :
                                                                                                                    • Address_line_2 :
                                                                                                                      • Registration_number : 3007636114
                                                                                                                        • Address_line_1 : Augartenstr. 1

        Device Registration and Listings

        • 2 ::
            • Pma_number :
              • Proprietary_name ::
                  • 0 : Urine Pregnancy Card
                • Products ::
                    • 0 ::
                        • Created_date : 2009-07-08
                          • Product_code : JHI
                            • Openfda ::
                                • Regulation_number : 862.1155
                                  • Medical_specialty_description : Clinical Chemistry
                                    • Device_class : 2
                                      • Device_name : Visual, Pregnancy Hcg, Prescription Use
                                    • Owner_operator_number : 10029582
                                      • Exempt :
                                • K_number :
                                  • Establishment_type ::
                                      • 0 : Manufacture Medical Device for Another Party (Contract Manufacturer)
                                    • Registration ::
                                        • Iso_country_code : CN
                                          • City : Shapingba Dist. Chongqing
                                            • Initial_importer_flag : N
                                              • Name : Chong Qing Teco Huayi Pharm Co.
                                                • Status_code : 1
                                                  • Zip_code :
                                                    • Fei_number : 3006621318
                                                      • Postal_code : 401332
                                                        • Reg_expiry_date_year : 2018
                                                          • Owner_operator ::
                                                              • Contact_address ::
                                                                  • Iso_country_code : CN
                                                                    • City : Shapingba Dist.
                                                                      • State_province : Chongqing
                                                                        • Postal_code : 401332
                                                                          • Address_1 : 1st Std. Workshop 2-402, No. 98,
                                                                            • Address_2 : Xiyuan 2nd Road,
                                                                              • State_code : CN-50
                                                                            • Owner_operator_number : 10029582
                                                                              • Official_correspondent ::
                                                                                • Firm_name : Chong Qing Teco Huayi Pharm. Co.
                                                                              • Us_agent ::
                                                                                  • Iso_country_code : US
                                                                                    • City : Anaheim
                                                                                      • State_code : CA
                                                                                        • Bus_phone_area_code : 714
                                                                                          • Name : KC.Chen
                                                                                            • Address_line_2 :
                                                                                              • Fax_area_code : 714
                                                                                                • Bus_phone_extn :
                                                                                                  • Address_line_1 : 1268 North Lakeview Avenue
                                                                                                    • Postal_code :
                                                                                                      • Fax_num : 4631169
                                                                                                        • Business_name : Teco Diagnostics
                                                                                                          • Bus_phone_num : 4631111
                                                                                                            • Email_address : kc@tecodiagnostics.com
                                                                                                              • Zip_code : 92807
                                                                                                            • State_code :
                                                                                                              • Address_line_2 : Xiyuan 2nd Road,
                                                                                                                • Registration_number : 3006621318
                                                                                                                  • Address_line_1 : 1st Std. Workshop 2-402, No. 98,

          Device Registration and Listings

          • 3 ::
              • Pma_number :
                • Proprietary_name ::
                    • 0 : INTRAMEDULLARY NAIL SYSTEM, LOCKING SCREW, NAIL CAP
                  • Products ::
                      • 0 ::
                          • Created_date : 2013-04-19
                            • Product_code : JDS
                              • Openfda ::
                                  • Regulation_number : 888.3030
                                    • Medical_specialty_description : Orthopedic
                                      • Device_class : 2
                                        • Device_name : Nail, Fixation, Bone
                                      • Owner_operator_number : 10029425
                                        • Exempt :
                                  • K_number :
                                    • Establishment_type ::
                                        • 0 : Sterilize Medical Device for Another Party (Contract Sterilizer)
                                      • Registration ::
                                          • Iso_country_code : US
                                            • City : West Memphis
                                              • Initial_importer_flag : N
                                                • Name : Sterigenics US LLC
                                                  • Status_code : 1
                                                    • Zip_code : 72301
                                                      • Fei_number : 3002907620
                                                        • Postal_code :
                                                          • Reg_expiry_date_year : 2018
                                                            • Owner_operator ::
                                                                • Contact_address ::
                                                                    • Iso_country_code : US
                                                                      • City : Oak Brook
                                                                        • State_province :
                                                                          • Postal_code : 60523
                                                                            • Address_1 : 2015 Spring Road
                                                                              • Address_2 : Suite 650
                                                                                • State_code : IL
                                                                              • Owner_operator_number : 10029425
                                                                                • Official_correspondent ::
                                                                                    • Middle_initial :
                                                                                      • Subaccount_company_name :
                                                                                        • First_name : Aaron
                                                                                          • Last_name : DeMent
                                                                                            • Phone_number : x-630-9281700-x
                                                                                          • Firm_name : Sotera Health LLC
                                                                                        • Us_agent ::
                                                                                          • State_code : AR
                                                                                            • Address_line_2 :
                                                                                              • Registration_number : 3002907620
                                                                                                • Address_line_1 : 1700 College Blvd.

            Device Registration and Listings

            • 4 ::
                • Pma_number :
                  • Proprietary_name ::
                      • 0 : R3 MULTI-HOLE SHELLS AND 36MM XLPE ACETABULAR LINERS
                    • Products ::
                        • 0 ::
                            • Created_date : 2013-04-22
                              • Product_code : MBL
                                • Openfda ::
                                    • Regulation_number : 888.3358
                                      • Medical_specialty_description : Orthopedic
                                        • Device_class : 2
                                          • Device_name : Prosthesis, Hip, Semi-Constrained, Uncemented, Metal/Polymer, Porous
                                        • Owner_operator_number : 10029425
                                          • Exempt :
                                    • K_number :
                                      • Establishment_type ::
                                          • 0 : Sterilize Medical Device for Another Party (Contract Sterilizer)
                                        • Registration ::
                                            • Iso_country_code : US
                                              • City : West Memphis
                                                • Initial_importer_flag : N
                                                  • Name : Sterigenics US LLC
                                                    • Status_code : 1
                                                      • Zip_code : 72301
                                                        • Fei_number : 3002907620
                                                          • Postal_code :
                                                            • Reg_expiry_date_year : 2018
                                                              • Owner_operator ::
                                                                  • Contact_address ::
                                                                      • Iso_country_code : US
                                                                        • City : Oak Brook
                                                                          • State_province :
                                                                            • Postal_code : 60523
                                                                              • Address_1 : 2015 Spring Road
                                                                                • Address_2 : Suite 650
                                                                                  • State_code : IL
                                                                                • Owner_operator_number : 10029425
                                                                                  • Official_correspondent ::
                                                                                      • Middle_initial :
                                                                                        • Subaccount_company_name :
                                                                                          • First_name : Aaron
                                                                                            • Last_name : DeMent
                                                                                              • Phone_number : x-630-9281700-x
                                                                                            • Firm_name : Sotera Health LLC
                                                                                          • Us_agent ::
                                                                                            • State_code : AR
                                                                                              • Address_line_2 :
                                                                                                • Registration_number : 3002907620
                                                                                                  • Address_line_1 : 1700 College Blvd.