Toric Intraocular Lens
by Henan Simedice Biotechnologies Co., Ltd. 363 variants
Ref ST7Model ST1, ST2, ST3, ST4, ST5, ST6, ST7, ST8, ST9,ST10
Active
CE MDR
Valid until
1 Dec 2029
FDA recalls
Not applicable
Documents
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | Number697420025P030102090301VC 06974200251996 | Date10 Mar 2026 | StatusActive |
Certificates
- 6128787TD02 Active
Technical documentation EU MDR
- Certifier
- DEKRA Certification B.V. 0344
- Issued
- 1 Jun 2025
- Expires
- 1 Jun 2030
- 6128787CE01 Active
Quality management system EU MDR
- Certifier
- DEKRA Certification B.V. 0344
- Issued
- 15 Jan 2026
- Expires
- 1 Dec 2029
- Reason
- Add device or group
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
European Union — CE/MDR Active
Specification
- Device Name
- Toric Intraocular Lens
- Model / Reference
- ST1, ST2, ST3, ST4, ST5, ST6, ST7, ST8, ST9, ST10
- Primary DI / UDI-DI
- 06974200251996
- Basic UDI-DI
- 697420025P030102090301VC
- Direct Marketing DI
- 06974200251996
- EMDN Code
- P030102090301 IOLs, APHAKIC, MONOFOCAL, TORIC, HYDROPHOBIC ACRYLIC
- Device Class
- Class IIb
- EU market of registration
- Italy
Manufacturer details
- EUDAMED SRN
- CN-MF-000017957
- Authorised representative
- MedNet EC-REP C IIb GmbH DE-AR-000011194
Other devices from Henan Simedice Biotechnologies Co., Ltd.
See all devices from Henan Simedice Biotechnologies Co., Ltd. →
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