Tonometer
by Shenzhen Aist Industrial Co., Ltd.
Ref 06980175830050Model SK-5000A，SK-5000B，SK-P，SW-500，GT-600，YZ-7A，SK-R，ST-1000，ST-1000A，AT-800
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 | Number698017583AIST05L8 06980175830050 | 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- Withdrawn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
- Tonometer
- Model / Reference
- SK-5000A，SK-5000B，SK-P，SW-500，GT-600，YZ-7A，SK-R，ST-1000，ST-1000A，AT-800, 06980175830050
- Primary DI / UDI-DI
- 06980175830050
- Basic UDI-DI
- 698017583AIST05L8
- 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