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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
- 08809126642840 EUDAMED08806712010410 EUDAMED08806712007915 EUDAMED08806712010021 EUDAMED08806712007908 EUDAMED08806712006963 EUDAMED
- Basic UDI-DI
- 8806712CGM001PS EUDAMED
- EMDN Code
- Z1204011585 INVASIVE BLOOD SUGAR MONITORING SYSTEMS, SINGLE–USE SENSORS EUDAMEDZ1204011501 NON INVASIVE BLOOD SUGAR MONITORING SYSTEMS EUDAMED
Classification
- Device Class
- Class IIb EUDAMED
- Market of Registration
- Germany EUDAMEDCroatia EUDAMEDItaly EUDAMEDCzechia EUDAMEDSpain EUDAMEDPoland 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 (6)
- EUDAMED 5dbe14e3-9b50-418f-9f15-f90c04b196fd 61 fields · synced Oct 5, 2026
- EUDAMED f630d4fc-0d28-42ab-b100-e19825c9a99f 61 fields · synced Jun 18, 2026
- EUDAMED efb9e1de-bac0-4dcc-b7d2-153c649ab7c4 61 fields · synced Jun 20, 2026
- EUDAMED d4140782-6f17-453a-8493-70e7b1d62658 61 fields · synced Jul 10, 2026
- EUDAMED 9a0629b7-35f0-4bf0-83d8-7fa1aca155d7 61 fields · synced Jul 30, 2026
- EUDAMED 9399dab6-0ead-4426-869b-82bfd1fa0976 61 fields · synced Oct 5, 2026