Twist-off lancet (use with lancing device)
by Tianjin Huahong Technology Co., Ltd. 80 variants
Ref NoModel I, II, III, V, VI, VII, VIII, IX
Active
CE MDR
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/MDR | Number69571386TOL01YF 06957138616938 | Date5 Jun 2023 | StatusActive |
Certificates
EUDAMED lists no certificate for this device's Basic UDI-DI.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
European Union — CE/MDR Active
Specification
- Device Name
- Twist-off lancet (use with lancing device)
- Model / Reference
- I, II, III, V, VI, VII, VIII, IX, No
- Primary DI / UDI-DI
- 06957138616938
- Basic UDI-DI
- 69571386TOL01YF
- Unit of Use DI
- 56957138616933
- EMDN Code
- V010402 Lancets without safety systems, single-use
- Device Class
- Class IIa
- EU market of registration
- Netherlands
Manufacturer details
- EUDAMED SRN
- CN-MF-000015849
- Authorised representative
- Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001
Other devices from Tianjin Huahong Technology Co., Ltd.
Properties
Other properties (12)
- 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