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Combined external fixator
EUDAMEDClass I (EU MDR)
Ref ZH1516 D6xD2.5-3.5，D4.0-5.0
Identity
- Trade Name
- Combined external fixator EUDAMED
- Device Name
- Combined external fixator EUDAMED
- Model / Reference
- ZH1516 D6xD2.5-3.5，D4.0-5.0 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06973137576387 EUDAMED
- Basic UDI-DI
- 697313757638LH 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 | 697313757638LH | 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 f17a03ca-2bbd-49e5-a80f-47e2fddb35af 61 fields · synced Jun 19, 2026