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Bone Rongeurs
EUDAMEDClass I (EU MDR)
Ref IMC-54-119Model IMC54119Ref IMC-54-107Model IMC54107
Identity
- Trade Name
- BONE RONGEURS EUDAMED
- Device Name
- Bone rongeur EUDAMED
- Model / Reference
- IMC54119 EUDAMEDIMC-54-119 EUDAMEDIMC54107 EUDAMEDIMC-54-107 EUDAMED
Identifiers
- Primary DI / UDI-DI
- ++G375IMC54119MN EUDAMED++G375IMC54107MF EUDAMED
- Basic UDI-DI
- B-++G375IMC54119MN EUDAMEDB-++G375IMC54107MF EUDAMED
- EMDN Code
- L091302 BONE RONGEURS, 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
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Bone Rongeurs by Immane Corporation — Class I — MDD — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-++G375IMC54119MN | Class I | Active |
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Manufacturer
- Manufacturer
- Immane Corporation
- EUDAMED SRN
- PK-MF-000035233
- Authorised Representative
- CS Active LV-AR-000011602
Sources (2)
- EUDAMED f25d838b-ac07-4174-9888-5bc8b3f3af98 61 fields · synced Jul 18, 2026
- EUDAMED 3cbe502b-dc5f-4fcc-b937-97857ed4e477 61 fields · synced May 18, 2026