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Rightest Blood Glucose Monitoring System

EUDAMEDFDA 510(k)

Class IVD Annex II List B (EU MDR)

Ref 550G01Model GM550510(k) K120423

by Bionime Corporation

Identity

Trade Name: Rightest Blood Glucose Monitoring System EUDAMED
Device Name: Blood Glucose Monitoring System EUDAMED
Model / Reference: GM550 EUDAMED
550G01 EUDAMED

Identifiers

Primary DI / UDI-DI: D-GM550UC EUDAMED
Basic UDI-DI: B-GM550UC EUDAMED
510(k) Number: K120423 FDA 510(k)
FDA Product Code: NBW FDA 510(k)
EMDN Code: W0101060101,W01010699,W0201060102 EUDAMED

Classification

Device Class: Class IVD Annex II List B EUDAMED
Class II FDA 510(k)
Legislation / Framework: 21 CFR Part 862.1345 FDA 510(k)
Regulation Number: 862.1345 FDA 510(k)
Market of Registration: Slovakia EUDAMED
Advisory Committee: Clinical Chemistry FDA 510(k)
FDA Decision: SESE Substantially Equivalent FDA 510(k)

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 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

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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 ad4bef9d-4698-4cbd-80da-0e20e781d47a 61 fields · synced Oct 6, 2026
FDA 510(k) K120423 24 fields · synced May 18, 2026