Techno Cut
by Niraj Industries Pvt. Ltd. India EUDAMED
Ref 4118
EMDN V010102
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | Number1000315516 | Date20 Aug 2026 | StatusActive |
Coverage
- Active
- Not covered
European Union — CE/MDR Active
Certificates
- 1000315516 Amended
Quality management system EU MDR
- Notified body
- Notified body 0297
- Issued
- 20 Aug 2026
- Expires
- 11 Jun 2030
- Reason
- Mnf data change
Specification
- Model / Reference
- 4118
- Primary DI / UDI-DI
- 18904233141181
- Basic UDI-DI
- 89042331V01WV
- Direct Marketing DI
- 18904233141181
- EMDN Code
- V010102 Scalpels without safety systems, single-use
- Device Class
- Class IIa
- Market of Registration
- Malta
Manufacturer details
- EUDAMED SRN
- IN-MF-000020562
- Authorised representative
- Advena Limited MT-AR-000000234
Other devices from Niraj Industries Pvt. Ltd.
Properties & raw data
Show properties, registry sources and raw records
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
Sources (1)
- EUDAMED b18ea03f-f244-4fc6-8af8-5f0da8dc9191