Freedom380_4Care_BL Metha
Ref T4812
Active
CE MDR
Valid until
14 Aug 2029
FDA recalls
Not applicable
Documents
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | NumberKR24/00000065 | Date2 Sep 2026 | StatusActive |
Certificates
- KR24/00000065 Active
Quality management system EU MDR
- Certifier
- SGS Belgium NV 1639
- Issued
- 2 Sep 2026
- Expires
- 14 Aug 2029
- Reason
- Other
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
European Union — CE/MDR Active
Specification
- Device Name
- Soft Contact Lens
- Model / Reference
- T4812
- Primary DI / UDI-DI
- 8800190045DD070200MG8S, 8800190045DD071100MG8U, 8800190045DD070100MG8F
- Basic UDI-DI
- 8800190047841PLAHWIOW7, 8800190047841SPOHWIO6B
- EMDN Code
- Q0210040102, Q021004010101
- Device Class
- Class IIa
- Special Device Type
- Standard soft contact lenses
- EU market of registration
- Netherlands
Manufacturer details
- EUDAMED SRN
- KR-MF-000022687
- Authorised representative
- Contact Lens Service GmbH DE-AR-000016174
Other devices from Interojo Inc.
Properties
Other properties (12)
- Implantable: No
- Reusable: No
- Contains Latex: No
- Reprocessed: 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