VISTHESIA 1.5% intra
Ref 003500-0071-642Model VISTHESIA
Expiring
CE MDR
Valid until
1 Sep 2027
FDA recalls
Not applicable
Documents
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | Number2250469CE01 | Date8 Sep 2026 | StatusExpiring |
Certificates
- 2250469TD01 Active
Technical documentation EU MDR
- Certifier
- DEKRA Certification B.V. 0344
- Issued
- 12 Aug 2025
- Expires
- 1 Aug 2030
- 2250469CE01 Expiring
Quality management system EU MDR
- Certifier
- DEKRA Certification B.V. 0344
- Issued
- 8 Sep 2026
- Expires
- 1 Sep 2027
- Reason
- Add device or group
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
European Union — CE/MDR Expiring
Specification
- Device Name
- Ophthalmic Viscosurgical Device
- Model / Reference
- VISTHESIA, 003500-0071-642
- Primary DI / UDI-DI
- 05060105141058
- Basic UDI-DI
- 506010514_OVD005_JZ
- EMDN Code
- Q02030301 Ophthalmology, hyaluronic acid and derivatives
- Device Class
- Class III
- EU market of registration
- Germany
Manufacturer details
- EUDAMED SRN
- GB-MF-000019761
- Authorised representative
- Carl Zeiss Meditec AG DE-AR-000007733
Other devices from Hyaltech Ltd.
Properties
Other properties (11)
- 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