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Offset reamer handle - large AO - Dual coupling
EUDAMEDClass IIa (EU MDR)
Ref 922061Ref 50244501Ref FH 269563Ref 50244524
Identity
- Trade Name
- Offset reamer handle - large AO - Dual coupling EUDAMEDOffset reamer handle - large AO - Dual coupling (NC) EUDAMED
- Device Name
- Offset Reamer Handle EUDAMED
- Model / Reference
- 922061 EUDAMED50244501 EUDAMEDFH 269563 EUDAMED50244524 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 07630055307019 EUDAMED07630055305763 EUDAMED07630055306982 EUDAMED07630055303851 EUDAMED
- Basic UDI-DI
- 7630055300502445ORHBT EUDAMED
- Direct Marketing DI
- 07630055307019 EUDAMED07630055305763 EUDAMED07630055306982 EUDAMED07630055303851 EUDAMED
- EMDN Code
- L0999 ORTHOPAEDIC AND TRAUMATOLOGICAL SURGERY INSTRUMENTS, REUSABLE - OTHER EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Austria EUDAMEDFrance 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
Offset reamer handle - large AO - Dual coupling by Incipio Devices SA — Class IIa — 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 | 7630055300502445ORHBT | Class IIa | Active |
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Manufacturer
- Manufacturer
- Incipio Devices SA
- EUDAMED SRN
- CH-MF-000030518
- Authorised Representative
- MDSS GmbH DE-AR-000005430
Sources (4)
- EUDAMED 617b6190-1055-4bc9-ab38-f7366abed924 61 fields · synced Jul 27, 2026
- EUDAMED 3d6d38e8-5051-4dee-8acf-62992c90b313 61 fields · synced May 16, 2026
- EUDAMED 5fce142f-7609-42c7-871f-e3e3b1e63dda 61 fields · synced May 17, 2026
- EUDAMED 2fdf9042-d600-40a7-afd3-e704decd32fc 61 fields · synced May 17, 2026