Identity
- Device Name
- Buckley Bone Osteotome 2mm, 16cm EUDAMED
- Model / Reference
- 28.0040.02 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08964003618841 EUDAMED
- Basic UDI-DI
- 896400361889640036188419M EUDAMED
- EMDN Code
- L090401 ORTHOPAEDIC SURGERY OSTEOTOMES, 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
Buckley Bone Osteotome 2mm, 16cm by Crimson International — 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 | 896400361889640036188419M | Class I | Active |
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Manufacturer
- Manufacturer
- Crimson International
- EUDAMED SRN
- PK-MF-000035275
- Authorised Representative
- ANTEX MEDI SOLUTION DE-AR-000008078
Sources (1)
- EUDAMED 48bdfea2-6cca-4dde-be61-9a8e00bd9cfa 61 fields · synced Jul 10, 2026