XPER Technology ß-Ketone Test Strips(50pcs/Box)(Procheck Advance)

EUDAMED

Class IVD devices for self-testing (EU MDR)

Ref TD-4631

by TaiDoc Technology Corporation

Identity

Trade Name: XPER Technology ß-Ketone Test Strips(50pcs/Box)(Procheck Advance) EUDAMED
Device Name: XPER Technology ß-Ketone Test Strips (Non-Sterile) EUDAMED
Model / Reference: TD-4631 EUDAMED

Identifiers

Primary DI / UDI-DI: 04713106020006 EUDAMED
Basic UDI-DI: B-04713106020006 EUDAMED
EMDN Code: W0101060110 KETONE TEST STRIPS (Β-HYDROXYBUTYRATE TEST STRIPS) EUDAMED

Classification

Device Class: Class IVD devices for self-testing EUDAMED
Market of Registration: Ireland EUDAMED

Clinical & Handling

Sterile

EUDAMED

Human Tissues

EUDAMED

Animal Tissues

EUDAMED

Microbial Substances

EUDAMED

Reagent

Yes

EUDAMED

Self Testing

Yes

EUDAMED

Near-Patient Testing

Yes

EUDAMED

Professional Testing

Yes

EUDAMED

Companion Diagnostics

EUDAMED

Surgical Instrument

Yes

EUDAMED

XPER Technology ß-Ketone Test Strips(50pcs/Box)(Procheck Advance) by Taidoc Technology Corporation — Class IVD devices for self-testing — IVDD — listed in…

Authorization Coverage (European Union — 27 member states)

Regulatory Authorizations

European Union Active

CE/IVDD

Source	Region	Type	Cert / Approval No.	Class	Status
EUDAMED	European Union	CE/IVDD	B-04713106020006	Class IVD devices for self-testing	Active

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Manufacturer

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

Sources (1)

EUDAMED 75898556-96dd-4ebc-a67e-075de0ba7a9f 61 fields · synced Jul 9, 2026