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Osteotome XL
EUDAMEDClass I (EU MDR)
Ref 00200733 endocon catalogue Model Arthroplasty revision system
by endocon GmbH
Identity
- Trade Name
- Osteotome XL EUDAMED
- Device Name
- Revisionsinstrumentensystem EUDAMED
- Model / Reference
- Arthroplasty revision system EUDAMED00200733 endocon catalogue EUDAMED
Identifiers
- Primary DI / UDI-DI
- 42514018019948 EUDAMED
- Basic UDI-DI
- 4251401801512Q3 EUDAMED
- Direct Marketing DI
- 42514018019948 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
Yes
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Osteotome XL by endocon GmbH — 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 | 4251401801512Q3 | Class I | Active |
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Manufacturer
- Manufacturer
- endocon GmbH
- EUDAMED SRN
- DE-MF-000020703
Sources (1)
- EUDAMED 42dc9b36-bae6-4e5c-83d6-eba1d50d9a36 61 fields · synced Sep 17, 2026