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Offset reamer handle - Handle
EUDAMEDClass IIa (EU MDR)
Ref 131-174/01Ref 50244504Ref 50246404
Identity
- Trade Name
- Offset reamer handle - Handle EUDAMED
- Device Name
- Offset Reamer Handle EUDAMED
- Model / Reference
- 131-174/01 EUDAMED50244504 EUDAMED50246404 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 07630055306807 EUDAMED07630055307170 EUDAMED07630055307149 EUDAMED07630055307231 EUDAMED07630055306357 EUDAMED
- Basic UDI-DI
- 7630055300502445ORHBT EUDAMED
- Direct Marketing DI
- 07630055306807 EUDAMED07630055307170 EUDAMED07630055307149 EUDAMED07630055307231 EUDAMED07630055306357 EUDAMED
- EMDN Code
- L0999 ORTHOPAEDIC AND TRAUMATOLOGICAL SURGERY INSTRUMENTS, REUSABLE - OTHER EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Germany EUDAMEDAustria 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 - Handle 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 (5)
- EUDAMED 9c01b2d7-5e13-45cb-a2dc-96d4a94664ab 61 fields · synced Aug 3, 2026
- EUDAMED c4c03a51-e28e-4361-b075-e8333f7e3f61 61 fields · synced May 17, 2026
- EUDAMED a7262fac-b9d0-49a2-8cf7-3ba37a36610a 61 fields · synced May 17, 2026
- EUDAMED 99c4ca3e-8ba8-4377-8900-754a26233116 61 fields · synced May 18, 2026
- EUDAMED b44064d3-7551-456e-85ce-e38f2c7d5bc6 61 fields · synced May 19, 2026