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High Offset Reamer Handle - Stryker Z/H - Tri coupling
EUDAMEDClass IIa (EU MDR)
Ref 1440-4010
Identity
- Trade Name
- High Offset Reamer Handle - Stryker Z/H - Tri coupling EUDAMED
- Device Name
- Offset Reamer Handle EUDAMED
- Model / Reference
- 1440-4010 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 07630055306319 EUDAMED
- Basic UDI-DI
- 7630055300502445ORHBT 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
High Offset Reamer Handle - Stryker Z/H - Tri 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 (1)
- EUDAMED 634622ee-d49a-47de-9d0a-43137c19cc1a 61 fields · synced May 29, 2026