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Monkeypox Virus DNA Detection Kit (Real-Time PCR)

EUDAMED

Class IVD General (EU MDR)

Ref 24 Tests/KitRef 48 Tests/KitRef 96 Tests/Kit

by Avioq Bio-tech Co., Ltd.

Identity

Device Name
Monkeypox Virus DNA Detection Kit (Real-Time PCR) EUDAMED
Model / Reference
24 Tests/Kit EUDAMED
48 Tests/Kit EUDAMED
96 Tests/Kit EUDAMED

Identifiers

Primary DI / UDI-DI
06975166200219 EUDAMED
06975166200226 EUDAMED
06975166200233 EUDAMED
Basic UDI-DI
B-06975166200219 EUDAMED
B-06975166200226 EUDAMED
B-06975166200233 EUDAMED
EMDN Code
W0101060199 BLOOD TEST STRIPS (CC) - RAPID TESTS AND "POINT OF CARE" - OTHER EUDAMED
W0105900102 REAGENTS FOR DNA AND/OR RNA AMPLIFICATION AND/OR DETECTION: BACTERIA AND/OR VIRUS EUDAMED

Classification

Device Class
Class IVD General 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

No

EUDAMED

Near-Patient Testing

No

EUDAMED

Professional Testing

Yes

EUDAMED

Companion Diagnostics

No

EUDAMED

Surgical Instrument

No

EUDAMED

Monkeypox Virus DNA Detection Kit (Real-Time PCR) by Avioq Bio-tech Co., Ltd. — Class IVD General — IVDD — listed in EUDAMED — regulatory data on deviCERTS

Authorization Coverage (European Union — 27 member states)

Regulatory Authorizations

European Union Active

CE/IVDD

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Manufacturer

Manufacturer
Avioq Bio-tech Co., Ltd.
EUDAMED SRN
CN-MF-000048146
Authorised Representative
SUNGO Europe B.V. NL-AR-000000247

Sources (4)

  • EUDAMED d8221768-f9c6-4d9d-9e3d-70d59391c665 61 fields · synced Jul 15, 2026
  • EUDAMED 21a4b35e-a88c-4427-a9ab-0a10016bba1d 61 fields · synced Jun 19, 2026
  • EUDAMED 9e7b3666-7b41-4e87-89c1-ba55b99ea23f 61 fields · synced Jul 13, 2026
  • EUDAMED d6c26c0b-a21e-4d99-8743-fdb8a465dfe9 61 fields · synced Jul 15, 2026