05993023021815
by Medicontur Medical Engineering Ltd. Hungary EUDAMED
Ref 05993023021815Model A46R
EMDN P030102090202
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | Number599302A46RFZ | Date21 May 2026 | StatusActive |
Coverage
- Active
- Not covered
European Union — CE/MDR Active
Certificates
- 2024-MDR/QS-070 Issued
Quality management system EU MDR
- Notified body
- 3EC International a.s. 2265
- Issued
- 12 Dec 2024
- Expires
- 10 Nov 2028
- 2024-MDR/TD-070 Issued
Technical documentation EU MDR
- Notified body
- 3EC International a.s. 2265
- Issued
- 12 Dec 2024
- Expires
- 10 Nov 2028
Specification
- Model / Reference
- A46R, 05993023021815
- Primary DI / UDI-DI
- 05993023021815
- Basic UDI-DI
- 599302A46RFZ
- EMDN Code
- P030102090202 IOLs, APHAKIC, MONOFOCAL, ASPHERIC, HYDROPHILIC ACRYLIC
- Device Class
- Class IIb
- Market of Registration
- Bulgaria
Manufacturer details
- EUDAMED SRN
- HU-MF-000024195
Properties & raw data
Show properties, registry sources and raw records
Other properties (12)
- Reusable: No
- Contains Latex: No
- Reprocessed: No
- Sutures: 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 b4d85975-8092-49d9-ac15-175d23b77649