Lite3
by Sterilance Medical (Suzhou) Inc.
Part of a family of 154 devices: see the family page
Ref 05-112812
Lite3 (05-112812) is a Class IIa device made by Sterilance Medical (Suzhou) Inc., registered in EUDAMED on 20 Feb 2023 (Basic UDI-DI 6945630105BH), active as of 22 Oct 2026.
Active
CE MDR
Valid until
No date given
FDA recalls
Not applicable
Documents
None linked in EUDAMED
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | Number6945630105BH 16945630116961 | Date20 Feb 2023 | StatusActive |
Official records
- EUDAMED public site 6945630105BH
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
European Union — CE/MDR Active
Specification
- Device name
- Disposable Safety Lancets
- Model / reference
- 05-112812
- Primary DI / UDI-DI
- 16945630116961
- Basic UDI-DI
- 6945630105BH
- Unit of use DI
- 06945630116964
- EMDN code
- V010401 Lancets with 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
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