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ISE blood quality control
EUDAMEDClass IVD General (EU MDR)
Ref 3001264Model Low：5×4mLRef 3025269Model High: Dissolved liquid: 4mL×1bottle，Freeze-dried powder: 0.18g×1bottleRef 3024568Model Low: Dissolved liquid: 4mL×1bottle，Freeze-dried powder: 0.18g×1bottleRef 3025268Model Low: Dissolved liquid: 4mL×5bottle，Freeze-dried powder: 0.18g×5bottle
Identity
- Trade Name
- ISE blood quality control EUDAMED
- Device Name
- ISE blood quality control EUDAMED
- Model / Reference
- Low：5×4mL EUDAMED3001264 EUDAMEDHigh: Dissolved liquid: 4mL×1bottle，Freeze-dried powder: 0.18g×1bottle EUDAMED3025269 EUDAMEDLow: Dissolved liquid: 4mL×1bottle，Freeze-dried powder: 0.18g×1bottle EUDAMED3024568 EUDAMEDLow: Dissolved liquid: 4mL×5bottle，Freeze-dried powder: 0.18g×5bottle EUDAMED3025268 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06942202261527 EUDAMED06942202230929 EUDAMED06942202226519 EUDAMED06942202230912 EUDAMED
- Basic UDI-DI
- B-06942202261527 EUDAMEDB-06942202230929 EUDAMEDB-06942202226519 EUDAMEDB-06942202230912 EUDAMED
- EMDN Code
- W0101050199 MULTICOMPONENT CONTROLS (CC) - 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
ISE blood quality control 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-06942202261527 | 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 (4)
- EUDAMED 2aae027c-85fe-47cb-bf3d-705b275baba1 61 fields · synced Jul 28, 2026
- EUDAMED 63f95bb3-8302-41ef-a8a6-17793e835f5e 61 fields · synced Jul 9, 2026
- EUDAMED 78381d87-9d59-43fd-a44e-3f5dc9f570de 61 fields · synced Jul 14, 2026
- EUDAMED 12e02de3-6c86-44b2-a702-c0cc6c2a4d28 61 fields · synced Jul 16, 2026