SteriLance
by Sterilance Medical (Suzhou) Inc. 142 variants
Ref Soft 30G
Active
CE MDR
Valid until
No date given
FDA recalls
Not applicable
Documents
None linked in EUDAMED
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | Number6945630101B9 16945630139380 | 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- Withdrawn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
- Device name
- Disposable Blood Lancets
- Model / reference
- Soft 30G
- Primary DI / UDI-DI
- 16945630139380
- Basic UDI-DI
- 6945630101B9
- Unit of use DI
- 06945630139383
- EMDN code
- V010402 Lancets without safety systems, single-use
- Device class
- Class IIa
- EU registration type
- Standard device
- EU market of registration
- Italy
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 (13)
- Sterilise before use: No
- Implantable: No
- Reusable: No
- Contains latex: No
- Reprocessed single-use device: No
- Contains CMR substances (carcinogenic, mutagenic or toxic to reproduction): No
- Incorporates a substance derived from human blood or plasma: No
- Contains human tissues or cells: No
- Contains animal tissues or cells: No
- Contains endocrine-disrupting substances: No
- Administering medicine: No
- Measuring function: No
- Incorporates a medicinal substance: No