Identity
- Trade Name
- Offset reamer handle - Body EUDAMED
- Device Name
- Offset Reamer Handle EUDAMED
- Model / Reference
- 50244505 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 07630055305923 EUDAMED07630055306364 EUDAMED07630055307187 EUDAMED
- Basic UDI-DI
- 7630055300502445ORHBT EUDAMED
- Direct Marketing DI
- 07630055305923 EUDAMED07630055306364 EUDAMED07630055307187 EUDAMED
- EMDN Code
- L0999 ORTHOPAEDIC AND TRAUMATOLOGICAL SURGERY INSTRUMENTS, REUSABLE - OTHER EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Austria 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 - Body 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 (3)
- EUDAMED cb0a463e-c91e-4de9-8c4e-86783914a384 61 fields · synced Jul 26, 2026
- EUDAMED 3e705074-32ba-4176-8868-4e4624295827 61 fields · synced May 17, 2026
- EUDAMED b2bf5b6e-daa1-4921-9b97-72c08771948d 61 fields · synced May 19, 2026