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Scalpel handle
EUDAMEDClass I (EU MDR)
Ref IMC-05-114-03Model IMC0511403Model IMC51051
Identity
- Trade Name
- Scalpel handle EUDAMED
- Device Name
- Scalpel handle EUDAMEDTooth extracting forceps EUDAMED
- Model / Reference
- IMC0511403 EUDAMEDIMC-05-114-03 EUDAMEDIMC51051 EUDAMED
Identifiers
- Primary DI / UDI-DI
- G375IMC05114030 EUDAMED
- Basic UDI-DI
- ++G375IMC51051LQ EUDAMEDB-G375IMC05114030 EUDAMED
- EMDN Code
- L010103 HANDLES FOR SCALPELS, 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
Scalpel handle by Immane Corporation — Class I — MDD, MDR — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDD
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | ++G375IMC51051LQ | Class I | Active |
| EUDAMED | European Union | CE/MDR | ++G375IMC51051LQ | 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 cdd7aaa4-61fe-4e27-8a48-aa2f97fe3db7 61 fields · synced Jun 19, 2026
- EUDAMED bf356737-2e3b-497f-991b-b6d4d60aa371 61 fields · synced May 17, 2026