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Osteotome w/15
EUDAMEDClass I (EU MDR)
Ref PDL632Model Reusable instrumentation
Identity
- Trade Name
- Osteotome w/15 EUDAMED
- Model / Reference
- Reusable instrumentation EUDAMEDPDL632 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00843193112125 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
Osteotome w/15 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 c0eaf6a8-64a6-490f-9249-a1c021eaff6f 61 fields · synced Jul 9, 2026