Auto Refractometer / Keratometer
by Shenzhen Aist Industrial Co., Ltd.
Ref 06980175830012Model ARK-X , ARK-DX, RK-800, FA-9500K, FA-6000A, FA-6500K, AT-9800K, HAR-680
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 | Number698017583AIST01KY 06980175830012 | Date15 Jul 2026 | 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- Withdrawn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
- Auto Refractometer / Keratometer
- Model / Reference
- ARK-X, ARK-DX, RK-800, FA-9500K, FA-6000A, FA-6500K, AT-9800K, HAR-680, 06980175830012
- Primary DI / UDI-DI
- 06980175830012
- Basic UDI-DI
- 698017583AIST01KY
- EMDN Code
- V9099 Various devices not included in other classes - other
- Device Class
- Class I
- Market of Registration
- Spain
Manufacturer details
- EUDAMED SRN
- CN-MF-000057177
- Authorised representative
- RIOMAVIX SOCIEDAD LIMITADA ES-AR-000001202
Other devices from Shenzhen Aist Industrial 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