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ALLYcgm Continuous Glucose Monitoring System
EUDAMEDClass IIb (EU MDR)
Ref CGM-ST-004
by i-SENS, Inc.
Identity
- Trade Name
- ALLYcgm Continuous Glucose Monitoring System EUDAMED
- Device Name
- Continuous Glucose Monitoring System EUDAMED
- Model / Reference
- CGM-ST-004 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08806712009568 EUDAMED
- Basic UDI-DI
- 8806712CGM001PS EUDAMED
- EMDN Code
- Z1204011585 INVASIVE BLOOD SUGAR MONITORING SYSTEMS, SINGLE–USE SENSORS EUDAMED
Classification
- Device Class
- Class IIb EUDAMED
- Market of Registration
- Ireland 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
ALLYcgm 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 68a7cc68-7f0a-438b-b328-a58557f60a4e 61 fields · synced Jul 13, 2026