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Mobile Application For Blood Glucose Monitoring System
EUDAMEDClass IVD Annex II List B (EU MDR)
Ref GP920Model Rightest GP920
Identity
- Device Name
- Mobile Application For Blood Glucose Monitoring System EUDAMED
- Model / Reference
- Rightest GP920 EUDAMEDGP920 EUDAMED
Identifiers
- Primary DI / UDI-DI
- D-GP920VC EUDAMED
- Basic UDI-DI
- B-GP920VC EUDAMED
- EMDN Code
- W020106019092 VARIOUS DIABETES MONITORING INSTRUMENTS - IVD MEDICAL DEVICE SOFTWARE EUDAMED
Classification
- Device Class
- Class IVD Annex II List B EUDAMED
- Special Device Type
- -1202 EUDAMED
- Market of Registration
- Netherlands EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Microbial Substances
No
EUDAMED
Reagent
No
EUDAMED
Self Testing
Yes
EUDAMED
Near-Patient Testing
Yes
EUDAMED
Professional Testing
No
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
No
EUDAMED
Mobile Application For Blood Glucose Monitoring System by Bionime Corporation — Class IVD Annex II List B — IVDD — listed in EUDAMED
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/IVDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/IVDD | B-GP920VC | Class IVD Annex II List B | Active |
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Manufacturer
- Manufacturer
- Bionime Corporation
- EUDAMED SRN
- TW-MF-000008450
- Authorised Representative
- Emergo Europe B.V. NL-AR-000000116
Sources (1)
- EUDAMED 309be5db-35ae-4d26-bc3c-0b302a2fdfd3 61 fields · synced Jul 30, 2026