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CareSens Air Continuous Glucose Monitoring System
EUDAMEDClass IIb (EU MDR)
Ref CGM-ST-002
by i-SENS, Inc.
Identity
- Trade Name
- CareSens Air Continuous Glucose Monitoring System EUDAMED
- Device Name
- Continuous Glucose Monitoring System EUDAMED
- Model / Reference
- CGM-ST-002 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08806712006048 EUDAMED
- Basic UDI-DI
- 8806712CGM001PS EUDAMED
- EMDN Code
- Z1204011501 NON INVASIVE BLOOD SUGAR MONITORING SYSTEMS EUDAMED
Classification
- Device Class
- Class IIb EUDAMED
- Market of Registration
- Netherlands EUDAMED
Clinical & Handling
Sterile
Yes
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
Yes
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
CareSens Air Continuous Glucose Monitoring System by i-SENS, Inc. — Class IIb — MDR — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 8806712CGM001PS | Class IIb | 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 9ea547b7-51e5-4d9e-923f-d27467cbb976 61 fields · synced Jun 19, 2026