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Trial Bipolar Head
EUDAMEDClass I (EU MDR)
Ref B04016-3Ref B04016-5Ref B08022Ref B08017Ref B08021Ref B04016-4Ref B04016-6Ref B08024Ref B08018Ref B04016-2
Identity
- Device Name
- Trial Bipolar Head EUDAMED
- Model / Reference
- B04016-3 EUDAMEDB04016-5 EUDAMEDB08022 EUDAMEDB08017 EUDAMEDB08021 EUDAMEDB04016-4 EUDAMEDB04016-6 EUDAMEDB08024 EUDAMEDB08018 EUDAMEDB04016-2 EUDAMED
Identifiers
- Primary DI / UDI-DI
- D-CNMF0000201152210H8 EUDAMEDD-CNMF0000201152212HC EUDAMEDD-CNMF0000201152319HX EUDAMEDD-CNMF0000201152314HM EUDAMEDD-CNMF0000201152318HV EUDAMEDD-CNMF0000201152211HA EUDAMEDD-CNMF0000201152213HE EUDAMEDD-CNMF0000201152321HJ EUDAMEDD-CNMF0000201152315HP EUDAMEDD-CNMF0000201152209HP EUDAMED
- Basic UDI-DI
- B-CNMF0000201152210H8 EUDAMEDB-CNMF0000201152212HC EUDAMEDB-CNMF0000201152319HX EUDAMEDB-CNMF0000201152314HM EUDAMEDB-CNMF0000201152318HV EUDAMEDB-CNMF0000201152211HA EUDAMEDB-CNMF0000201152213HE EUDAMEDB-CNMF0000201152321HJ EUDAMEDB-CNMF0000201152315HP EUDAMEDB-CNMF0000201152209HP EUDAMED
- EMDN Code
- L091104 ORTHOPAEDIC PROSTHESES POSITIONERS, REUSABLE EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Portugal EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
Yes
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Category: Orthopaedic implant impactor, reusable
Trial Bipolar Head by Tianjin Zhengtian Medical Instrument Co., Ltd. — Class I — MDD — listed in EUDAMED — regulatory data on deviCERTS
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Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-CNMF0000201152210H8 | Class I | Active |
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Manufacturer
- Manufacturer
- Tianjin Zhengtian Medical Instrument Co., Ltd.
- EUDAMED SRN
- CN-MF-000020115
- Authorised Representative
- Inion Oy FI-AR-000046224
Sources (10)
- EUDAMED fcf01b46-a4d8-466f-8fd3-691b844d2ea2 61 fields · synced Jul 31, 2026
- EUDAMED 8715d3d1-b6b3-4edc-a5f1-fdd05c003d71 61 fields · synced May 16, 2026
- EUDAMED 181cfdc6-0ab3-4439-a512-7cfb6d9a1cfe 61 fields · synced May 17, 2026
- EUDAMED f221a43f-7f12-4cd2-bab3-ca37197ae055 61 fields · synced May 18, 2026
- EUDAMED 6b2ab6ba-9c26-4e27-82a0-88dc9dcc89f6 61 fields · synced May 18, 2026
- EUDAMED 1f5a4526-3f1a-4258-95c8-4ff9ef0338ff 61 fields · synced May 18, 2026
- EUDAMED d5f109de-da69-4f3c-bbab-43ad2ecc90bb 61 fields · synced May 18, 2026
- EUDAMED 4465ba0f-ab3d-400b-89af-ca8266c8ad1f 61 fields · synced May 18, 2026
- EUDAMED 9fd4bd0f-097d-4b10-90ac-b4799a0bc6ca 61 fields · synced May 18, 2026
- EUDAMED f9649724-2556-444b-891d-22b49f72f006 61 fields · synced May 18, 2026