Identity
- Device Name
- Distractor 8mm EUDAMED
- Model / Reference
- 30115026 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06941977564833 EUDAMED
- Basic UDI-DI
- B-06941977564833 EUDAMED
- EMDN Code
- L0919 ORTHOPAEDIC AND TRAUMATOLOGICAL SURGERY INSTRUMENT KITS, REUSABLE EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- France EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
Yes
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
Distractor 8mm by Shanghai Sanyou Medical 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-06941977564833 | Class I | Active |
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Manufacturer
- Manufacturer
- Shanghai Sanyou Medical Co., Ltd.
- EUDAMED SRN
- CN-MF-000004488
- Authorised Representative
- Wellkang Ltd XI-AR-000001836
Sources (1)
- EUDAMED d37ec08a-d867-450d-b17d-0ae361aa405c 61 fields · synced Jun 19, 2026