← Back to catalogue

Diagnostic Kit for Coxsackievirus A6 RNA (PCR-Fluorescence Probing)

EUDAMED

Class IVD General (EU MDR)

Ref DA0572Model Single tube, 10 tests/kitRef DA0570Model Large package, 10 tests/kitRef DA0571Model Large package, 48 tests/kit

by Daan Gene Co., Ltd.

Identity

Device Name
Diagnostic Kit for Coxsackievirus A6 RNA (PCR-Fluorescence Probing) EUDAMED
Model / Reference
Single tube, 10 tests/kit EUDAMED
DA0572 EUDAMED
Large package, 10 tests/kit EUDAMED
DA0570 EUDAMED
Large package, 48 tests/kit EUDAMED
DA0571 EUDAMED

Identifiers

Primary DI / UDI-DI
06928103005729 EUDAMED
06928103005705 EUDAMED
06928103005712 EUDAMED
Basic UDI-DI
B-06928103005729 EUDAMED
B-06928103005705 EUDAMED
B-06928103005712 EUDAMED
EMDN Code
W0105040502 ENTEROVIRUS - NA REAGENTS EUDAMED

Classification

Device Class
Class IVD General EUDAMED
Market of Registration
Germany EUDAMED

Clinical & Handling

Sterile

No

EUDAMED

Human Tissues

No

EUDAMED

Animal Tissues

No

EUDAMED

Microbial Substances

Yes

EUDAMED

Reagent

Yes

EUDAMED

Self Testing

No

EUDAMED

Near-Patient Testing

No

EUDAMED

Professional Testing

Yes

EUDAMED

Companion Diagnostics

No

EUDAMED

Surgical Instrument

No

EUDAMED

Diagnostic Kit for Coxsackievirus A6 RNA (PCR-Fluorescence Probing) by Daan Gene Co., Ltd. — Class IVD General — IVDD — listed in EUDAMED

Authorization Coverage (European Union — 27 member states)

Regulatory Authorizations

European Union Active

CE/IVDD

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer
Daan Gene Co., Ltd.
EUDAMED SRN
CN-MF-000025799
Authorised Representative
MDSS GmbH DE-AR-000005430

Sources (3)

  • EUDAMED cc605550-b758-4812-80ab-bb12c9c7a782 61 fields · synced Jul 27, 2026
  • EUDAMED 07a35384-c725-497f-bb26-eb754eef34b5 61 fields · synced May 18, 2026
  • EUDAMED 6358f070-77d9-4329-9c38-8edc455f40bd 61 fields · synced May 18, 2026