Primus-HD® Toric
by Eyebright Medical Technology (Beijing) Co., Ltd. 598 variants
Ref AT4UXL24,0.0DModel ATUXL, ATBXL
Active
CE MDR
Valid until
22 Sep 2031
FDA recalls
Not applicable
Documents
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | Number69528868B007SB 06926959129101 | Date28 Sep 2026 | StatusActive |
Certificates
- G70 086359 0021 Active
Technical documentation EU MDR
- Certifier
- TÜV SÜD Product Service GmbH 0123
- Issued
- 23 Sep 2026
- Expires
- 22 Sep 2031
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
European Union — CE/MDR Active
Specification
- Device Name
- Preloaded Intraocular Lens System
- Model / Reference
- ATUXL, ATBXL, AT4UXL24, 0.0D
- Primary DI / UDI-DI
- 06926959129101
- Basic UDI-DI
- 69528868B007SB
- EMDN Code
- P030102090301 IOLs, APHAKIC, MONOFOCAL, TORIC, HYDROPHOBIC ACRYLIC
- Device Class
- Class IIb
- EU 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
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