← Back to catalogue
RIGHTEST Blood Glucose Monitoring System GM700
EUDAMEDFDA 510(k)Class IVD Annex II List B (EU MDR)
Ref 700G01Model GM700Ref 762G01Model GM762510(k) K140210Ref 720G01Model GM720
Identity
- Trade Name
- RIGHTEST Blood Glucose Monitoring System GM700 EUDAMEDRIGHTEST Blood Glucose Monitoring System GM700 Pro 2 EUDAMEDRIGHTEST Blood Glucose Monitoring System GM720 EUDAMED
- Device Name
- Blood Glucose Monitoring System EUDAMED
- Model / Reference
- GM700 EUDAMED700G01 EUDAMEDGM762 EUDAMED762G01 EUDAMEDGM720 EUDAMED720G01 EUDAMED
Identifiers
- Primary DI / UDI-DI
- D-GM700U7 EUDAMEDD-GM762UV EUDAMEDD-GM720UD EUDAMED
- Basic UDI-DI
- B-GM700U7 EUDAMEDB-GM762UV EUDAMEDB-GM720UD EUDAMED
- EMDN Code
- W0101060101,W01010699,W0201060102 EUDAMED
Classification
- Device Class
- Class IVD Annex II List B EUDAMED
- Market of Registration
- Czechia EUDAMEDLithuania 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 Blood Glucose Monitoring System GM700 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
United States Active
FDA_510K
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 | K140210 | Class IVD Annex II List B | Active |
| FDA 510(k) | United States | FDA_510K | K141292 | Class IVD Annex II List B | Active |
| FDA 510(k) | United States | FDA_510K | K110737 | Class IVD Annex II List B | Active |
| EUDAMED | European Union | CE/IVDD | B-GM700U7 | Class IVD Annex II List B | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Bionime Corporation
- EUDAMED SRN
- TW-MF-000008450
- Authorised Representative
- Emergo Europe B.V. NL-AR-000000116
Sources (4)
- EUDAMED ae636492-6ebd-4a6c-896d-c874a92bfbf2 61 fields · synced Oct 6, 2026
- EUDAMED 5ce86d69-b53a-4f47-9102-37aad7845294 85 fields · synced May 18, 2026
- EUDAMED 7fab131e-a0c4-4a7e-b57b-7262b3f0bd0a 61 fields · synced Jul 24, 2026
- FDA 510(k) K140210 1 fields · synced Jun 9, 2026