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Control for Hematology Analyzer
EUDAMEDClass IVD General (EU MDR)
Ref 3001324Model Level 3: 2mlRef 3001325Model Level 1: 2ml
Identity
- Trade Name
- Control for Hematology Analyzer EUDAMED
- Device Name
- Control for Hematology Analyzer EUDAMED
- Model / Reference
- Level 3: 2ml EUDAMED3001324 EUDAMEDLevel 1: 2ml EUDAMED3001325 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06925794504340 EUDAMED06925794504326 EUDAMED
- Basic UDI-DI
- B-06925794504340 EUDAMEDB-06925794504326 EUDAMED
- EMDN Code
- W0103010599 HAEMATOLOGY CONTROLS - OTHER EUDAMED
Classification
- Device Class
- Class IVD General EUDAMED
- Market of Registration
- Austria EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
Yes
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
Control for Hematology Analyzer by Dirui Industrial Co., Ltd — Class IVD General — IVDD — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/IVDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/IVDD | B-06925794504340 | Class IVD General | Active |
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Manufacturer
- Manufacturer
- Dirui Industrial Co., Ltd
- EUDAMED SRN
- CN-MF-000001891
- Authorised Representative
- Emergo Europe B.V. NL-AR-000000116
Sources (2)
- EUDAMED 4f388794-6293-4c09-aa28-80244cbdcea9 61 fields · synced Jul 29, 2026
- EUDAMED 1464ec55-75bf-4b7b-a3b4-3d85df4a4946 61 fields · synced May 17, 2026