Alphacheck
by Promisemed Hangzhou Meditech Co., Ltd. 44 variants
Ref SL-21-24M2
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 | Number697122740SLYU | Date21 Oct 2025 | 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- Withdrawn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
- Safety Blood Lancets
- Model / Reference
- SL-21-24M2
- Primary DI / UDI-DI
- 06975965295881, 06971227409713
- Basic UDI-DI
- 697122740SLYU
- Unit of Use DI
- 86975965295887, 86971227409719
- EMDN Code
- V010401 Lancets with safety systems, single-use
- Device Class
- Class IIa
- EU market of registration
- Sweden
Manufacturer details
- EUDAMED SRN
- CN-MF-000008465
- Authorised representative
- Obelis s.a. BE-AR-000000106
Other devices from Promisemed Hangzhou Meditech Co., Ltd.
See all devices from Promisemed Hangzhou Meditech 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