Identity
- Trade Name
- GIMA EUDAMED
- Device Name
- Disposable Scalpels including safety types EUDAMED
- Model / Reference
- 27063 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 18903376032448 EUDAMED
- Basic UDI-DI
- 8903376DSWG EUDAMED
- Unit of Use DI
- 08903376032441 EUDAMED
- EMDN Code
- V010101 SCALPELS WITH SAFETY SYSTEMS, SINGLE-USE EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Italy EUDAMED
Clinical & Handling
Sterile
Yes
EUDAMED
Implantable
No
EUDAMED
Reusable
No
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
Gima by Razormed Inc. — 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 | 8903376DSWG | Class IIa | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Razormed Inc.
- EUDAMED SRN
- IN-MF-000012812
- Authorised Representative
- Advena Limited MT-AR-000000234
Sources (1)
- EUDAMED e90f3d58-50b0-4c66-bcf8-36b77214c56c 61 fields · synced Jul 8, 2026