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Continuous Glucose Monitoring App
EUDAMEDClass IIb (EU MDR)
Ref RC2112Model RC2112, RW1002Ref RC2111
Identity
- Device Name
- Continuous Glucose Monitoring App EUDAMED
- Model / Reference
- RC2112, RW1002 EUDAMEDRC2112 EUDAMEDRC2111 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06958590309307 EUDAMED06958590309291 EUDAMED
- Basic UDI-DI
- 69585903Z120401GXEANDQA EUDAMED69585903Z120401GXEIOSSK EUDAMED
- Direct Marketing DI
- 06958590309307 EUDAMED06958590309291 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
Continuous Glucose Monitoring App 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 | 69585903Z120401GXEANDQA | 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 (2)
- EUDAMED c2da964b-1569-4534-8a40-908c044423b2 61 fields · synced Jul 14, 2026
- EUDAMED 2072c179-46a7-4bf3-b29f-7b8c63cb4f03 61 fields · synced May 18, 2026