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Blood Gas/Ion/Metabolite Control
EUDAMEDClass IVD General (EU MDR)
Ref BQC-hct Level 1:2.0ml×5、Level 2:2.0ml×5、Level 3:2.0ml×5Ref BQC Level 1: 2.0ml×5、Level 2: 2.0ml×5、Level 3: 2.0ml×5
Identity
- Device Name
- Blood Gas/Ion/Metabolite Control EUDAMEDBlood Gas/Ion/Metabolite Control EUDAMED
- Model / Reference
- BQC-hct Level 1:2.0ml×5、Level 2:2.0ml×5、Level 3:2.0ml×5 EUDAMEDBQC Level 1: 2.0ml×5、Level 2: 2.0ml×5、Level 3: 2.0ml×5 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06972337857401 EUDAMED06972337852987 EUDAMED
- Basic UDI-DI
- B-06972337857401 EUDAMEDB-06972337852987 EUDAMED
- EMDN Code
- W0101060607 BLOOD GAS CONTROLS - ELECTRODES OR CASSETTE EUDAMED
Classification
- Device Class
- Class IVD General 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
Blood Gas/Ion/Metabolite Control by B&E Bio-Technology 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-06972337857401 | Class IVD General | Active |
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Manufacturer
- Manufacturer
- B&E Bio-Technology Co., Ltd.
- EUDAMED SRN
- CN-MF-000023256
- Authorised Representative
- SUNGO Europe B.V. NL-AR-000000247
Sources (2)
- EUDAMED f79ca730-ec7e-4214-83f3-4e897b771b90 61 fields · synced Jul 20, 2026
- EUDAMED e214bbe4-66d2-4781-af3c-9aeb1a016603 61 fields · synced May 18, 2026