Mc X11 Asp 22.0
by HumanOptics Holding AG Germany EUDAMED
Ref 00083300 EMDN P030102090202
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | Number04049154_PC_M2_H3_O2_C7 | Date7 Jul 2025 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
European Union — CE/MDR Active
Certificates
- 44911221836 Supplemented
Quality management system EU MDR
- Notified body
- Notified body 0044
- Issued
- 10 Jun 2026
- Expires
- 12 Jun 2030
- Reason
- Other
- 44912221836 Supplemented
Technical documentation EU MDR
- Notified body
- Notified body 0044
- Issued
- 10 Jun 2026
- Expires
- 12 Jun 2030
- Reason
- Other
Specification
- Device Name
- IOLs, aphakic / Family MC X11 ASP
- Model / Reference
- 00083300
- Primary DI / UDI-DI
- 04049154009350
- Basic UDI-DI
- 04049154_PC_M2_H3_O2_C7
- EMDN Code
- P030102090202 IOLs, APHAKIC, MONOFOCAL, ASPHERIC, HYDROPHILIC ACRYLIC
- Device Class
- Class IIb
- Market of Registration
- Germany
Manufacturer details
- EUDAMED SRN
- DE-MF-000017892
Other devices from HumanOptics Holding AG
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 04049154009350|04049154_PC_M2_H3_O2_C7