Mediware
by Sterilance Medical (Suzhou) Inc. 14 variants
Ref "steel B2 01500"
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 | Number6945630150BN 16945630135290 | Date17 Feb 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- Withdrawn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
- Disposable Steel Lancets
- Model / Reference
- "steel B2 01500"
- Primary DI / UDI-DI
- 16945630135290
- Basic UDI-DI
- 6945630150BN
- Unit of Use DI
- 06945630135293
- EMDN Code
- A019013 Percutaneous needles
- Device Class
- Class IIa
- EU market of registration
- Austria
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