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GlucoX Blood Glucose Monitoring System

EUDAMEDFDA 510(k)

Class IVD Annex II List B (EU MDR)

Ref TD-4183510(k) K080283

by TaiDoc Technology Corporation

Identity

Trade Name
GlucoX Blood Glucose Monitoring System EUDAMED
Device Name
Blood Glucose Monitoring System EUDAMED
Model / Reference
TD-4183 EUDAMED

Identifiers

Primary DI / UDI-DI
04713106020044 EUDAMED
Basic UDI-DI
B-04713106020044 EUDAMED
510(k) Number
K080283 FDA 510(k)
FDA Product Code
NBW FDA 510(k)
EMDN Code
W0201060102 BLOOD GLUCOSE METERS 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
Ireland 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

Yes

EUDAMED

Companion Diagnostics

No

EUDAMED

Surgical Instrument

Yes

EUDAMED

GlucoX Blood Glucose Monitoring System by Taidoc Technology 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

European Union Active

CE/IVDD

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Manufacturer

Manufacturer
TaiDoc Technology Corporation
EUDAMED SRN
TW-MF-000017956
Authorised Representative
MedNet EC-REP GmbH DE-AR-000000002

Sources (2)

  • EUDAMED 82a2b2a3-96f4-45dc-bded-71b87ba31b65 61 fields · synced Oct 6, 2026
  • FDA 510(k) K080283 24 fields · synced May 18, 2026