Enožariščno steklo z dioptrijo
by Alcom d.o.o. EUDAMED
Active
Ref Individual Single VisionModel ISV
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | Number383007999ISVMY | Date27 May 2026 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
European Union — CE/MDR Active
Specification
- Device Name
- Individual Single Vision, Single Vision, HD, MyoControl, MyoControl Individual
- Model / Reference
- ISV, Individual Single Vision
- Primary DI / UDI-DI
- 03830079990110, 03830079990158
- Basic UDI-DI
- 383007999ISVMY
- EMDN Code
- Q0210010101 Monofocal organic ophthalmic lenses
- Device Class
- Class I
- Market of Registration
- Slovenia
Manufacturer details
- EUDAMED SRN
- SI-MF-000004685
Other devices from Alcom d.o.o.
Properties
Show properties
Other properties (13)
- Sterile: No
- 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