Clinical Trial Kit: ESC2000™ - Illuminated Cabinet, ETDRS 2000 Series Distance Charts (13ft/4m) and Floor Stand
Ref 500701Model Illuminated Cabinets and vision acuity testing and screening charts, sets 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++G211GGILCXK +G2115007011W | Date17 Jun 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- Withdrawn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
- Illuminated Cabinets and vision acuity testing and screening charts, sets and accessories
- Model / Reference
- Illuminated Cabinets and vision acuity testing and screening charts, sets and accessories, 500701
- Primary DI / UDI-DI
- +G2115007011W
- Basic UDI-DI
- ++G211GGILCXK
- 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