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Coated Femoral Tibial Spreader Small Grip Handle
EUDAMEDClass I (EU MDR)
Ref 1850-01-SG
Identity
- Trade Name
- Coated Femoral Tibial Spreader Small Grip Handle EUDAMED
- Device Name
- Retractor EUDAMED
- Model / Reference
- 1850-01-SG EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00840277100566 EUDAMED
- Basic UDI-DI
- 8402771INNORETRACT016A EUDAMED
- Direct Marketing DI
- 00840277100566 EUDAMED
- EMDN Code
- L0915 SPREADERS AND RETRACTORS FOR ORTHOPAEDIC SURGERY, 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
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
Coated Femoral Tibial Spreader Small Grip Handle by Innomed, Inc. — 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 | 8402771INNORETRACT016A | Class I | Active |
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Manufacturer
- Manufacturer
- Innomed, Inc.
- EUDAMED SRN
- US-MF-000014761
- Authorised Representative
- MediMark Europe Sarl. FR-AR-000000182
Sources (1)
- EUDAMED cd04118d-ac6a-4678-9e15-67dce9898e1b 61 fields · synced Jun 19, 2026