Identity
- Trade Name
- Unilateral integrated external fixator EUDAMED
- Device Name
- Unilateral integrated external fixator EUDAMED
- Model / Reference
- DB05 L=230 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06973137570170 EUDAMED
- Basic UDI-DI
- 697313757017KB 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
Unilateral integrated 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 | 697313757017KB | Class I | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Beijing Ruibaoli Medical Equipment Co., Ltd.
- EUDAMED SRN
- CN-MF-000042588
- Authorised Representative
- MedPath GmbH DE-AR-000000087
Sources (1)
- EUDAMED 63f9b01b-e1e4-4d39-93ed-00e5af2170ab 61 fields · synced Jun 18, 2026