05993022946027
by Medicontur Medical Engineering Ltd.
Ref 05993022946027Model 877FABY
Active
CE MDR
Valid until
10 Nov 2028
FDA recalls
Not applicable
Documents
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | Number599302877FABYM8 05993022946027 | Date21 May 2026 | StatusActive |
Certificates
- 2023-MDR/QS-047/A Active
Quality management system EU MDR
- Certifier
- 3EC International a.s. 2265
- Issued
- 22 Dec 2025
- Expires
- 10 Nov 2028
- Reason
- Other
- 2023-MDR/TD-047/A Active
Technical documentation EU MDR
- Certifier
- 3EC International a.s. 2265
- Issued
- 22 Dec 2025
- Expires
- 10 Nov 2028
- Reason
- Other
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
European Union — CE/MDR Active
Specification
- Model / Reference
- 877FABY, 05993022946027
- Primary DI / UDI-DI
- 05993022946027
- Basic UDI-DI
- 599302877FABYM8
- EMDN Code
- P030102090201 IOLs, APHAKIC, MONOFOCAL, ASPHERIC, HYDROPHOBIC ACRYLIC
- Device Class
- Class IIb
- EU market of registration
- Czechia
Manufacturer details
- EUDAMED SRN
- HU-MF-000024195
Other devices from Medicontur Medical Engineering Ltd.
Properties
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