Identity
- Trade Name
- CHISEL 10MM EUDAMED
- Model / Reference
- Reusable instrumentation EUDAMEDSFW867R EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00843193114594 EUDAMED
- Basic UDI-DI
- 08431931InstrumentsU5 EUDAMED
- EMDN Code
- L091199 ORTHOPAEDIC PROSTHETICS INSTRUMENTS, REUSABLE - OTHER 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
Chisel 10mm 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 2331f44a-bd53-4c2f-8001-f069837c38d7 61 fields · synced Aug 3, 2026