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55 Degree Constrained U Joint Drive Chain
EUDAMEDClass IIa (EU MDR)
Ref 481100585
Identity
- Trade Name
- 55 Degree Constrained U Joint Drive Chain EUDAMED
- Device Name
- Offset Reamer Handle EUDAMED
- Model / Reference
- 481100585 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 07630055306661 EUDAMED
- Basic UDI-DI
- 7630055300502445ORHBT EUDAMED
- Direct Marketing DI
- 07630055306661 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
55 Degree Constrained U Joint Drive Chain 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 (1)
- EUDAMED a06b049a-9c6e-4d70-94d5-6695e1441d62 61 fields · synced May 22, 2026