Gima
Ref 27065
Expiring
CE MDR
Valid until
14 Jul 2027
FDA recalls
Not applicable
Documents
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | Number28620239980 | Date6 Mar 2026 | StatusExpiring |
Certificates
- 28620239980 Expiring
Quality management system EU MDR
- Certifier
- Intertek Medical Notified Body AB 2862
- Issued
- 6 Mar 2026
- Expires
- 14 Jul 2027
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
European Union — CE/MDR Expiring
Specification
- Device Name
- Disposable Scalpels including safety types
- Model / Reference
- 27065
- Primary DI / UDI-DI
- 18903376032462
- Basic UDI-DI
- 8903376DSWG
- Unit of Use DI
- 08903376032465
- EMDN Code
- V010101 Scalpels with safety systems, single-use
- Device Class
- Class IIa
- EU market of registration
- Italy
Manufacturer details
- EUDAMED SRN
- IN-MF-000012812
- Authorised representative
- Advena Limited MT-AR-000000234
Other devices from Razormed Inc.
Properties
Other properties (12)
- Implantable: No
- Reusable: No
- Contains Latex: No
- Reprocessed: No
- CMR Substance: No
- Human-derived: No
- Human Tissues: No
- Animal Tissues: No
- Endocrine Disruptor: No
- Administering Medicine: No
- Measuring Function: No
- Incorporates Medicinal Product: No