Disposable Blood Lancets
by Sterilance Medical (Suzhou) Inc. 20 variants
Ref 01-0128
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 | Number6945630101B9 | Date9 Feb 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- Withdrawn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
- Trade Name
- Sterilance Disposable Blood Lancets
- Device Name
- Disposable Blood Lancets
- Model / Reference
- 01-0128
- Primary DI / UDI-DI
- 16945630122818, 06945630115752, 16945630115742, 16945630122825, 16945630125369
- Basic UDI-DI
- 6945630101B9
- Unit of Use DI
- 06945630122811, 06945630115745, 06945630122828, 06945630125362
- EMDN Code
- V010402 Lancets without safety systems, single-use
- Device Class
- Class IIa
- EU market of registration
- AustriaGermany
Manufacturer details
- EUDAMED SRN
- CN-MF-000002860
- Authorised representative
- Emergo Europe B.V. NL-AR-000000116
Other devices from Sterilance Medical (Suzhou) Inc.
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