Blood glucose meter
by Ningbo Co-healthy Biotechnology Co., Ltd
Ref SN000001Model KH-100
Active
CE IVDD
Valid until
Not listed
FDA recalls
Not applicable
Documents
None linked in EUDAMED
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/IVDD | NumberB-06954912922223 06954912922223 | Date15 Jul 2025 | StatusActive |
Certificates
EUDAMED lists no certificate for this device's Basic UDI-DI.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
European Union — CE/IVDD Active
Specification
- Device Name
- Blood glucose meter
- Model / Reference
- KH-100, SN000001
- Primary DI / UDI-DI
- 06954912922223
- Basic UDI-DI
- B-06954912922223
- EMDN Code
- V9099 Various devices not included in other classes - other
- Device Class
- Class IVD devices for self-testing
- EU market of registration
- Spain
Manufacturer details
- EUDAMED SRN
- CN-MF-000047420
- Authorised representative
- RIOMAVIX SOCIEDAD LIMITADA ES-AR-000001202
Properties
Other properties (7)
- Sterile: No
- Human Tissues: No
- Animal Tissues: No
- Microbial Substances: No
- Reagent: No
- Near-Patient Testing: No
- Surgical Instrument: No