DiaTrust
by DiaTrust Medical Co., Ltd 26 variants
Ref P8125-301-16, PJ2-202-16, S8125-301-16, PC2-201-16, SC2-201-16, PJ2-301-16, B101-1001
DiaTrust (P8125-301-16) is an in vitro diagnostic device (EU IVDR Class A; EMDN category microscope slides) made by DiaTrust Medical Co., Ltd, registered in EUDAMED on 9 Mar 2023 (Basic UDI-DI 6974570461010BC), active as of 22 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 | Number6974570461010BC | Date9 Mar 2023 | StatusActive |
Official records
- EUDAMED public site 6974570461010BC
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- Withdrawn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
- Microscope Slide
- Model / reference
- P8125-301-16, PJ2-202-16, S8125-301-16, PC2-201-16, SC2-201-16, PJ2-301-16, B101-1001
- Primary DI / UDI-DI
- 06936700737660, 06936700776331, 06936700748338, 06936700739145, 06936700750485, 06936700776416, 06974570460110
- Basic UDI-DI
- 6974570461010BC
- Direct marketing DI
- 06936700737660069367007763310693670074833806936700739145069367007504850693670077641606974570460110
- EMDN code
- W0503900201 Microscope slides
- Device class
- Class A
- EU registration type
- Standard device
- EU market of registration
- Northern Ireland
Manufacturer details
- EUDAMED SRN
- CN-MF-000009279
- Authorised representative
- Wellkang Ltd XI-AR-000001836
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