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Handle For Trial Implant
EUDAMEDClass I (EU MDR)
Ref SFW565RModel Reusable instrumentation
Identity
- Trade Name
- HANDLE FOR TRIAL IMPLANT EUDAMED
- Model / Reference
- Reusable instrumentation EUDAMEDSFW565R EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00843193114662 EUDAMED
- Basic UDI-DI
- 08431931InstrumentsU5 EUDAMED
- EMDN Code
- L091104 ORTHOPAEDIC PROSTHESES POSITIONERS, REUSABLE EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Germany 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
Handle For Trial Implant by Centinel Spine, LLC — Class I — 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 | 08431931InstrumentsU5 | Class I | Active |
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Manufacturer
- Manufacturer
- Centinel Spine, LLC
- EUDAMED SRN
- US-MF-000013245
- Authorised Representative
- Emergo Europe B.V. NL-AR-000000116
Sources (1)
- EUDAMED eb5e236e-c393-43e6-9524-169c172657b4 61 fields · synced Jun 19, 2026