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RIGHTEST Max Dual Blood Glucose and Ketone Monitoring System
EUDAMEDFDA 510(k)Class IVD Annex II List B (EU MDR)
Ref 771K01Model GM771
Identity
- Trade Name
- RIGHTEST Max Dual Blood Glucose and Ketone Monitoring System EUDAMED
- Device Name
- Blood Glucose and Ketone Monitoring System EUDAMED
- Model / Reference
- GM771 EUDAMED771K01 EUDAMED
Identifiers
- Primary DI / UDI-DI
- D-GM771UW EUDAMED
- Basic UDI-DI
- B-GM771UW EUDAMED
- EMDN Code
- W0101060101,W0101060110,W01010699,W0201060102 EUDAMED
Classification
- Device Class
- Class IVD Annex II List B EUDAMED
- Market of Registration
- Germany EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Microbial Substances
No
EUDAMED
Reagent
Yes
EUDAMED
Self Testing
Yes
EUDAMED
Near-Patient Testing
Yes
EUDAMED
Professional Testing
No
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
No
EUDAMED
RIGHTEST Max Dual Blood Glucose and Ketone Monitoring System by Bionime Corporation — Class IVD Annex II List B — FDA_510K, IVDD — listed in EUDAMED, FDA 510(k)
Authorization Coverage (2 countries)
Regulatory Authorizations
United States Active
FDA_510K
European Union Active
CE/IVDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K173638 | Class IVD Annex II List B | Active |
| EUDAMED | European Union | CE/IVDD | B-GM771UW | 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 (2)
- EUDAMED 1ffa0f70-3240-4c22-a181-0e35f9fad1d7 61 fields · synced Oct 6, 2026
- FDA 510(k) K173638 1 fields · synced May 18, 2026