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i-Check Blood Gas Analyzer, Handheld
EUDAMEDClass A (EU MDR)
Ref i-Check 200Model i-Check i-Check 200Ref i-Check
Identity
- Device Name
- i-Check Blood Gas Analyzer,Handheld EUDAMED
- Model / Reference
- i-Check i-Check 200 EUDAMEDi-Check 200 EUDAMEDi-Check EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06972337852239 EUDAMED06972337852222 EUDAMED
- Basic UDI-DI
- 697233785i-CheckA012MJ EUDAMED
- EMDN Code
- W02029099 VARIOUS HEMATOLOGY / HISTOLOGY / CYTOLOGY INSTRUMENTS - OTHER 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
No
EUDAMED
Self Testing
No
EUDAMED
Near-Patient Testing
No
EUDAMED
Professional Testing
Yes
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
Yes
EUDAMED
New Device
No
EUDAMED
i-Check Blood Gas Analyzer, Handheld by B&E Bio-Technology 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 | 697233785i-CheckA012MJ | Class A | 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 7f73281e-6364-4db9-ae50-0f4bb29ef282 61 fields · synced Jul 27, 2026
- EUDAMED 405abb67-0a7f-41c1-8661-ec4fdd86cbe1 61 fields · synced May 17, 2026