Lc-04S
by Zenith Lab (Jiangsu) Co., Ltd
Ref LC-04S
Lc-04S is an in vitro diagnostic device (EU IVDR Class A; EMDN category centrifuges) made by Zenith Lab (Jiangsu) Co., Ltd, registered in EUDAMED on 30 Jul 2024 (Basic UDI-DI 697637433LC-04SF6), active as of 24 Oct 2026.
Active
CE IVDR
Valid until
No date given
FDA recalls
Not applicable
Documents
None, self-declared
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/IVDR | Number697637433LC-04SF6 06976374330071 | Date30 Jul 2024 | StatusActive |
Official records
- EUDAMED public site 697637433LC-04SF6
Certificates
No certifier certificate is listed. Devices of this class are self-declared by the manufacturer.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
European Union — CE/IVDR Active
Specification
- Device name
- Lc-04S
- Model / reference
- LC-04S
- Primary DI / UDI-DI
- 06976374330071
- Basic UDI-DI
- 697637433LC-04SF6
- EMDN code
- W02069003 Centrifuges
- Device class
- Class A
- EU registration type
- Standard device
- EU market of registration
- Germany
Manufacturer details
- EUDAMED SRN
- CN-MF-000026595
- Authorised representative
- Umedwings Netherlands B.V. NL-AR-000000444
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