Identity
- Trade Name
- Ganz Type PAO Osteotomy Chisel Angled EUDAMED
- Device Name
- Osteotome EUDAMED
- Model / Reference
- 1173 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00840277133250 EUDAMED
- Basic UDI-DI
- 8402771INNOOSTEO016V EUDAMED
- Direct Marketing DI
- 00840277133250 EUDAMED
- EMDN Code
- L090401 ORTHOPAEDIC SURGERY OSTEOTOMES, 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
Ganz Type PAO Osteotomy Chisel Angled 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 | 8402771INNOOSTEO016V | 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 73186797-c00a-4482-9939-ad0071707af1 61 fields · synced Jul 14, 2026