Vision traning software
by OMNILIGHT Technology Co., LTD China EUDAMED
Ref OLOE-A01, OLOE-A02
EMDN Z12129082
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | Number697665104OLOEA01YX | Date14 Sep 2023 | StatusActive |
Coverage
- Active
- Not covered
European Union — CE/MDR Active
Specification
- Device Name
- Vision training software
- Model / Reference
- OLOE-A01, OLOE-A02
- Primary DI / UDI-DI
- 06976651040013, 06976651040020
- Basic UDI-DI
- 697665104OLOEA01YX, 697665104OLOEA02YZ
- Direct Marketing DI
- 0697665104001306976651040020
- EMDN Code
- Z12129082 Various ophtalmology instruments - software accessories
- Device Class
- Class I
- Market of Registration
- Netherlands
Manufacturer details
- EUDAMED SRN
- CN-MF-000037401
- Authorised representative
- Kingsmead Service B.V. NL-AR-000002066
Properties & raw data
Show properties, registry sources and raw records
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
Sources (2)
- EUDAMED 8dd5a24f-b735-4f1b-a4ec-99e9ace96b5f
- EUDAMED 06976651040020|697665104OLOEA02YZ