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Blood Gas, Electrolyte, Metabolite Control
EUDAMEDClass IVD General (EU MDR)
Ref R-QP-A-1Model Level 1, 10 ampuls Level 2, 10 ampuls Level 3, 10 ampuls
Identity
- Trade Name
- Blood Gas, Electrolyte, Metabolite Control EUDAMED
- Device Name
- Blood Gas, Electrolyte, Metabolite Control EUDAMED
- Model / Reference
- Level 1, 10 ampuls Level 2, 10 ampuls Level 3, 10 ampuls EUDAMEDR-QP-A-1 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06978896416363 EUDAMED
- Basic UDI-DI
- B-06978896416363 EUDAMED
- EMDN Code
- W0101050199 MULTICOMPONENT CONTROLS (CC) - OTHER EUDAMED
Classification
- Device Class
- Class IVD General EUDAMED
- Market of Registration
- Romania EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Microbial Substances
Yes
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
Blood Gas, Electrolyte, Metabolite Control by Wuhan Easydiagnosis Biomedicine Co., Ltd. — Class IVD General — IVDD — listed in EUDAMED
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-06978896416363 | Class IVD General | Active |
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Manufacturer
- Manufacturer
- Wuhan Easydiagnosis Biomedicine Co., Ltd.
- EUDAMED SRN
- CN-MF-000019908
- Authorised Representative
- MedNet EC-REP GmbH DE-AR-000000002
Sources (1)
- EUDAMED 33603e45-96c3-4415-aae9-51ce5a4665d8 61 fields · synced Jun 19, 2026