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i-Smart 300 Cartridge
EUDAMEDClass C (EU MDR)
Ref POCBGCT001-200T3WModel POCBGCT001
by i-SENS, Inc.
Identity
- Trade Name
- i-Smart 300 Cartridge EUDAMED
- Device Name
- i-Smart 300 Cartridge EUDAMED
- Model / Reference
- POCBGCT001 EUDAMEDPOCBGCT001-200T3W EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08806712906218 EUDAMED
- Basic UDI-DI
- 8806712POCBGCT00123 EUDAMED
- EMDN Code
- W0101060610 BLOOD GAS INCL. ELECTROLYTES / METABOLITES - MULTI USE CASSETTE EUDAMED
Classification
- Device Class
- Class C EUDAMED
- Market of Registration
- France 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
New Device
No
EUDAMED
i-Smart 300 Cartridge by i-SENS, Inc. — Class C — 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 | 8806712POCBGCT00123 | Class C | 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 d1d4407b-167f-4939-872b-f882a9509a1e 61 fields · synced Jul 8, 2026