Identity
- Trade Name
- Combined external fixator EUDAMED
- Device Name
- Combined external fixator EUDAMED
- Model / Reference
- ZH1304 12holes EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06973137575373 EUDAMED
- Basic UDI-DI
- 697313757537LA EUDAMED
- EMDN Code
- P09120499 EXTERNAL BONE FIXATION SYSTEMS - OTHER EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Germany EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Combined external fixator by Beijing Ruibaoli Medical Equipment Co., Ltd. — Class I — MDR — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 697313757537LA | Class I | Active |
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Manufacturer
- Manufacturer
- Beijing Ruibaoli Medical Equipment Co., Ltd.
- EUDAMED SRN
- CN-MF-000042588
- Authorised Representative
- MedPath GmbH DE-AR-000000087
Sources (1)
- EUDAMED 6fa52074-1510-489c-8821-746cc8d2a7f7 61 fields · synced Oct 5, 2026