Prosert®
by Eyebright Medical Technology (Beijing) Co., Ltd. 1,000+ variants
Part of a family of 1,114 devices: see the family page
Ref A1ULP28, +34.5 DModel A1ULP, AQBXLP
Prosert® is a Class IIb device made by Eyebright Medical Technology (Beijing) Co., Ltd., registered in EUDAMED on 4 Dec 2025 (Basic UDI-DI 69528868B003S3) with CE/MDR certificate G70 086359 0019 valid until 25 Feb 2030, active as of 22 Oct 2026.
Active
CE MDR
Valid until
25 Feb 2030
FDA recalls
Not applicable
Documents
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | Number69528868B003S3 06952886896663 | Date4 Dec 2025 | StatusActive |
Official records
- EUDAMED public site 69528868B003S3
Certificates
- G70 086359 0019 Active
Technical documentation EU MDR
- Certifier
- TÜV SÜD Product Service GmbH 0123
- Issued
- 26 Feb 2025
- Expires
- 25 Feb 2030
Timeline
- Certificate issued EUDAMED G70 086359 0019
- Registered EUDAMED 69528868B003S3
- Certificate expires EUDAMED G70 086359 0019
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
European Union — CE/MDR Active
Specification
- Device name
- Preloaded Intraocular Lens System
- Model / reference
- A1ULP, AQBXLP, A1ULP28, +34.5 D
- Primary DI / UDI-DI
- 06952886896663
- Basic UDI-DI
- 69528868B003S3
- EMDN code
- P030102090201 IOLs, APHAKIC, MONOFOCAL, ASPHERIC, HYDROPHOBIC ACRYLIC
- Device class
- Class IIb
- EU registration type
- Standard device
- EU market of registration
- Germany
Manufacturer details
- EUDAMED SRN
- CN-MF-000003041
- Authorised representative
- Lotus NL B.V. NL-AR-000000121
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