Smartphone Eye Imaging Adaptor
by Visuscience Meditech Co., Ltd. EUDAMED
Active
Ref VPA-300Model VPA-200,VPA-300
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | Number697601515VPASC | Date16 Dec 2024 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
European Union — CE/MDR Active
Certificates
No notified-body certificate is listed. Devices of this class are self-declared by the manufacturer.
Specification
- Model / Reference
- VPA-200, VPA-300
- Primary DI / UDI-DI
- 06976015150013
- Basic UDI-DI
- 697601515VPASC
- EMDN Code
- Z12120199 Ophtalmology assessments and diagnosis instruments – other
- Device Class
- Class I
- Market of Registration
- Netherlands
Manufacturer details
- EUDAMED SRN
- CN-MF-000032898
- Authorised representative
- SUNGO Europe B.V. NL-AR-000000247
Other devices from Visuscience Meditech Co., Ltd.
Properties
Other properties (13)
- Sterile: No
- 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