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i-SmartCare 10 Blood Gas Analyzer
EUDAMEDClass A (EU MDR)
Ref POCBGAL002
by i-SENS, Inc.
Identity
- Trade Name
- i-SmartCare 10 Blood Gas Analyzer EUDAMED
- Device Name
- Blood Gas Analyzer EUDAMED
- Model / Reference
- POCBGAL002 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08806712901152 EUDAMED
- Basic UDI-DI
- 8806712POCBGAL002XL EUDAMED
- EMDN Code
- W0201040101 BLOOD GAS ANALYSERS - WITH CLASSIC PROFILE (pH, pO2, pCO2, HCT + electrolytes) EUDAMED
Classification
- Device Class
- Class A EUDAMED
- Market of Registration
- Germany 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-SmartCare 10 Blood Gas Analyzer by i-SENS, Inc. — 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 | 8806712POCBGAL002XL | Class A | Active |
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Manufacturer
- Manufacturer
- i-SENS, Inc.
- EUDAMED SRN
- KR-MF-000009173
- Authorised Representative
- Medical Technology Promedt Consulting GmbH DE-AR-000000085
Sources (1)
- EUDAMED d4b165ac-5868-4f1e-a6ca-f59fd29bf716 61 fields · synced Jul 29, 2026