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DiaTrust
EUDAMEDClass A (EU MDR)
Ref P8125-301-16Ref PJ2-202-16Ref S8125-301-16Ref PC2-201-16Ref SC2-201-16Ref PJ2-301-16Ref B101-1001
Identity
- Trade Name
- DiaTrust EUDAMED
- Device Name
- Microscope Slide EUDAMED
- Model / Reference
- P8125-301-16 EUDAMEDPJ2-202-16 EUDAMEDS8125-301-16 EUDAMEDPC2-201-16 EUDAMEDSC2-201-16 EUDAMEDPJ2-301-16 EUDAMEDB101-1001 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06936700737660 EUDAMED06936700776331 EUDAMED06936700748338 EUDAMED06936700739145 EUDAMED06936700750485 EUDAMED06936700776416 EUDAMED06974570460110 EUDAMED
- Basic UDI-DI
- 6974570461010BC EUDAMED
- Direct Marketing DI
- 06936700737660 EUDAMED06936700776331 EUDAMED06936700748338 EUDAMED06936700739145 EUDAMED06936700750485 EUDAMED06936700776416 EUDAMED06974570460110 EUDAMED
- EMDN Code
- W0503900201 MICROSCOPE SLIDES EUDAMED
Classification
- Device Class
- Class A EUDAMED
- Market of Registration
- Northern Ireland EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
Yes
EUDAMED
Animal Tissues
Yes
EUDAMED
Microbial Substances
Yes
EUDAMED
Reagent
No
EUDAMED
Self Testing
No
EUDAMED
Near-Patient Testing
No
EUDAMED
Professional Testing
Yes
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
No
EUDAMED
New Device
No
EUDAMED
Category: General specimen microscopy slide IVD, single-use
DiaTrust by DiaTrust Medical Co., Ltd — Class A — IVDR — listed in EUDAMED — regulatory data on deviCERTS
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Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/IVDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/IVDR | 6974570461010BC | Class A | Active |
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Manufacturer
- Manufacturer
- DiaTrust Medical Co., Ltd
- EUDAMED SRN
- CN-MF-000009279
- Authorised Representative
- Wellkang Ltd XI-AR-000001836
Sources (7)
- EUDAMED 71637084-3da2-4875-847a-265389560079 61 fields · synced Jul 31, 2026
- EUDAMED 291e889a-59dc-47c2-a13c-ebe1378c7172 61 fields · synced May 17, 2026
- EUDAMED f208a5ff-f365-49f9-854d-edc1690d1a20 61 fields · synced May 17, 2026
- EUDAMED 72cc4626-c80b-4715-bd22-b850cf0014c6 61 fields · synced May 18, 2026
- EUDAMED d1ef0592-a5f3-419a-a1b1-3aa96afc5c66 61 fields · synced May 18, 2026
- EUDAMED bffe33c0-ffd3-4fb7-bf1d-a1373197e99a 61 fields · synced May 18, 2026
- EUDAMED 8dc1b2cd-9f9d-4537-ac1c-8c57588c76d1 61 fields · synced May 18, 2026