Identity
- Trade Name
- Bipolar Trial Tray EUDAMED
- Device Name
- Non-sterile Orthopedic Manual Surgical Instruments EUDAMED
- Model / Reference
- F16AB-PA00412 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06934635756930 EUDAMED
- Basic UDI-DI
- B-06934635756930 EUDAMED
- EMDN Code
- L0919 ORTHOPAEDIC AND TRAUMATOLOGICAL SURGERY INSTRUMENT KITS, REUSABLE EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Germany 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
Bipolar Trial Tray by Wuhan Mindray Scientific Co., Ltd. — Class I — MDD — listed in EUDAMED — regulatory data on deviCERTS
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-06934635756930 | Class I | Active |
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Manufacturer
- Manufacturer
- Wuhan Mindray Scientific Co., Ltd.
- EUDAMED SRN
- CN-MF-000032692
- Authorised Representative
- Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001
Sources (1)
- EUDAMED b9cf5678-b28c-41ae-8812-0da8c39e7ea2 61 fields · synced Sep 18, 2026