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Chisel FR-078 -Flexible microstructure chisel -single use-
EUDAMEDClass IIa (EU MDR)
Ref FR-078 endocon catalogue Model chisel system for prosthesis removal
by endocon GmbH
Identity
- Trade Name
- Chisel FR-078 -Flexible microstructure chisel -single use- EUDAMED
- Device Name
- OrthoClast EUDAMED
- Model / Reference
- chisel system for prosthesis removal EUDAMEDFR-078 endocon catalogue EUDAMED
Identifiers
- Primary DI / UDI-DI
- 42514018000960 EUDAMED
- Basic UDI-DI
- 425140189970900096 EUDAMED
- Direct Marketing DI
- 42514018000960 EUDAMED
- EMDN Code
- L091101 ORTHOPAEDIC PROSTHESES AND TRAUMATOLOGICAL IMPLANTS EXTRACTORS, REUSABLE EUDAMED
Classification
- Device Class
- Class IIa 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 FR-078 -Flexible microstructure chisel -single use- by endocon GmbH — Class IIa — 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 | 425140189970900096 | Class IIa | Active |
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Manufacturer
- Manufacturer
- endocon GmbH
- EUDAMED SRN
- DE-MF-000020703
Sources (1)
- EUDAMED 8f871614-f356-4261-9693-e281e7af22f8 61 fields · synced Jul 10, 2026