Intraocular Lens
by Eyebright Medical Technology (Beijing) Co., Ltd. China EUDAMED
Ref AT5BX,+14.5DModel ATBX, ATUX EMDN P030102090301
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | Number69528868B006S9 | Date4 Sep 2026 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
European Union — CE/MDR Active
Certificates
- G70 086359 0021 Issued
Technical documentation EU MDR
- Notified body
- TÜV SÜD Product Service GmbH 0123
- Issued
- 23 Sep 2026
- Expires
- 22 Sep 2031
Specification
- Device Name
- Intraocular Lens
- Model / Reference
- ATBX, ATUX, AT5BX, +14.5D
- Primary DI / UDI-DI
- 06952886817910
- Basic UDI-DI
- 69528868B006S9
- EMDN Code
- P030102090301 IOLs, APHAKIC, MONOFOCAL, TORIC, HYDROPHOBIC ACRYLIC
- Device Class
- Class IIb
- Market of Registration
- Germany
Manufacturer details
- EUDAMED SRN
- CN-MF-000003041
- Authorised representative
- Lotus NL B.V. NL-AR-000000121
Other devices from Eyebright Medical Technology (Beijing) Co., Ltd.
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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 06952886817910|69528868B006S9