Laminated HRR Pseudoisochromatic Test, 4th Edition and Expanded Amsler Chart Set
Ref 730010Model Color Vision Tests and Accessories
Active
CE MDR
Valid until
Not listed
FDA recalls
Not applicable
Documents
None, self-declared
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | Number++G211GGCLRVISX9 +G2117300101U | Date28 Jul 2025 | StatusActive |
Certificates
No certifier certificate is listed. Devices of this class are self-declared by the manufacturer.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
European Union — CE/MDR Active
Specification
- Device Name
- Color Vision Tests and Accessories
- Model / Reference
- Color Vision Tests and Accessories, 730010
- Primary DI / UDI-DI
- +G2117300101U
- Basic UDI-DI
- ++G211GGCLRVISX9
- EMDN Code
- Q0299 Ophthalmic devices - other
- Device Class
- Class I
- EU market of registration
- Netherlands
Manufacturer details
- EUDAMED SRN
- US-MF-000008439
- Authorised representative
- Good-Lite B.V. NL-AR-000028608
Other devices from Good-Lite Company
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