Identity
- Trade Name
- WELLION EUDAMED
- Device Name
- Continuous Glucose Monitoring System Sensor EUDAMED
- Model / Reference
- G7-S01；G7-S01A；G7-S01B EUDAMEDWELL19-S14D EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06958590307617 EUDAMED
- Basic UDI-DI
- 69585903Z120401G7S2U EUDAMED
- EMDN Code
- Z1204011599 BLOOD SUGAR MONITORING SYSTEMS - OTHER EUDAMED
Classification
- Device Class
- Class IIb EUDAMED
- Market of Registration
- Austria 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
Wellion by Microtech Medical (hangzhou) Co., Ltd. — 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 | 69585903Z120401G7S2U | Class IIb | Active |
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Manufacturer
- Manufacturer
- MicroTech Medical (Hangzhou) Co., Ltd.
- EUDAMED SRN
- CN-MF-000001157
- Authorised Representative
- CMC Medical Devices & Drugs SL ES-AR-000000293
Sources (1)
- EUDAMED 61feb7b8-fb4a-4d07-a5f6-84e23b194b4a 61 fields · synced Jul 8, 2026