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Bionime Rightest GC300 Glucose Control Solution
EUDAMEDFDA 510(k)Class IVD Annex II List B (EU MDR)
Ref 300G16Model GC300
Identity
- Trade Name
- Bionime Rightest GC300 Glucose Control Solution EUDAMED
- Device Name
- Blood Glucose Control Solution EUDAMED
- Model / Reference
- GC300 EUDAMED300G16 EUDAMED
Identifiers
- Primary DI / UDI-DI
- D-GC300RD EUDAMED
- Basic UDI-DI
- B-GC300RD EUDAMED
- EMDN Code
- W0101050205 DIABETES CONTROLS EUDAMED
Classification
- Device Class
- Class IVD Annex II List B EUDAMED
- Market of Registration
- Austria 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
Bionime Rightest GC300 Glucose Control Solution 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 | K133003 | Class IVD Annex II List B | Active |
| EUDAMED | European Union | CE/IVDD | B-GC300RD | 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 d49269fc-82ea-4348-929a-eece7218dae9 61 fields · synced Jul 14, 2026
- FDA 510(k) K133003 1 fields · synced May 18, 2026