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Sample Diluent
EUDAMEDClass A (EU MDR)
Ref 3019901Ref 3019961Model Blood Coagulation
Identity
- Trade Name
- Sample Diluent EUDAMED
- Device Name
- Chemiluminescence Immunoassay Reagent EUDAMEDSample Diluent EUDAMED
- Model / Reference
- 3019901 EUDAMEDBlood Coagulation EUDAMED3019961 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06925794577429 EUDAMED06925794577542 EUDAMED
- Basic UDI-DI
- 69257945W01029003R02L EUDAMED69257945W0103020903R0PT EUDAMED
- EMDN Code
- W01029003 BUFFERS (UNASSIGNABLE), SUPPLEM. REAGENTS, ETC (IC) EUDAMEDW0103020903 BUFFERS (HAEMOSTASIS) EUDAMED
Classification
- Device Class
- Class A EUDAMED
- Market of Registration
- Austria EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Microbial Substances
No
EUDAMED
Reagent
Yes
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
Sample Diluent by Dirui Industrial Co., Ltd — Class A — IVDR — listed in EUDAMED — regulatory data on deviCERTS
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 | 69257945W01029003R02L | Class A | Active |
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Manufacturer
- Manufacturer
- Dirui Industrial Co., Ltd
- EUDAMED SRN
- CN-MF-000001891
- Authorised Representative
- SUNGO Europe B.V. NL-AR-000000247
Sources (2)
- EUDAMED 93758025-dda3-4d67-ab4f-eac995f8df3b 61 fields · synced Jul 31, 2026
- EUDAMED 2d11f406-9a85-4d68-bafa-0a62aa0e0f3b 61 fields · synced Jul 31, 2026