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Offset reamer handle - Stryker Z/H - Tri coupling
EUDAMEDClass IIa (EU MDR)
Ref 2016REAMRef 50244512Ref 50245118
Identity
- Trade Name
- Offset reamer handle - Stryker Z/H - Tri coupling EUDAMEDOffset reamer handle - Stryker Z/H - Tri coupling (NL) EUDAMED
- Device Name
- Offset Reamer Handle EUDAMED
- Model / Reference
- 2016REAM EUDAMED50244512 EUDAMED50245118 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 07630055307057 EUDAMED07630055305800 EUDAMED07630055307095 EUDAMED
- Basic UDI-DI
- 7630055300502445ORHBT EUDAMED
- Direct Marketing DI
- 07630055307057 EUDAMED07630055305800 EUDAMED07630055307095 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 - 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 (3)
- EUDAMED 858da89b-549f-4cf0-9e2a-f91efb0b9f5e 61 fields · synced Aug 2, 2026
- EUDAMED 9c5726de-b98b-416f-bdb7-7edea044a2b7 61 fields · synced May 18, 2026
- EUDAMED 161bde50-3a79-44b7-9255-d6f1603b4887 61 fields · synced May 18, 2026