Identity
- Trade Name
- CareSens Air Receiver EUDAMED
- Device Name
- Receiver EUDAMED
- Model / Reference
- CGM-R-001 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08806712010304 EUDAMED
- Basic UDI-DI
- 8806712CGMR001T5 EUDAMED
- EMDN Code
- Z1204011599 BLOOD SUGAR MONITORING SYSTEMS - OTHER EUDAMED
Classification
- Device Class
- Class IIb EUDAMED
- Market of Registration
- Italy EUDAMED
Clinical & Handling
Sterile
No
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 Receiver 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 | 8806712CGMR001T5 | 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 133a30a4-0f6c-42bb-a183-efa32240761f 61 fields · synced Jul 28, 2026