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2019-Novel Coronavirus, Influenza A and B virus nucleic acid test kit (Fluoresc…

EUDAMED

Class IVD General (EU MDR)

Ref R208T050B0C2Ref R20802T2048Ref R20803T2048

by Jiangsu Mole Bioscience Co., LTD.

Identity

Device Name
2019-Novel Coronavirus, Influenza A and B virus nucleic acid test kit (Fluorescent Probe-based real-time PCR assay) EUDAMED
Model / Reference
R208T050B0C2 EUDAMED
R20802T2048 EUDAMED
R20803T2048 EUDAMED

Identifiers

Primary DI / UDI-DI
06970895476133 EUDAMED
06970895475563 EUDAMED
06970895476010 EUDAMED
Basic UDI-DI
B-06970895476133 EUDAMED
B-06970895475563 EUDAMED
B-06970895476010 EUDAMED
EMDN Code
W0105041106 CORONAVIRUS - NA REAGENTS EUDAMED
W0105070503 RESPIRATORY TRACT INFECTIONS - MULTIPLEX NA REAGENTS EUDAMED

Classification

Device Class
Class IVD General EUDAMED
Market of Registration
Bulgaria 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

2019-Novel Coronavirus, Influenza A and B virus nucleic acid test kit (Fluoresc… by Jiangsu Mole Bioscience Co., LTD. — Class IVD General — IVDD — listed in…

Authorization Coverage (European Union — 27 member states)

Regulatory Authorizations

European Union Active

CE/IVDD

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Manufacturer

Manufacturer
Jiangsu Mole Bioscience Co., LTD.
EUDAMED SRN
CN-MF-000001539
Authorised Representative
SUNGO Europe B.V. NL-AR-000000247

Sources (3)

  • EUDAMED 55cd5a72-3f13-4942-a94f-d22383d99fc8 61 fields · synced Oct 6, 2026
  • EUDAMED 39b6d491-b3b5-462d-83f2-7a4c121ed25d 61 fields · synced May 18, 2026
  • EUDAMED ccbc3bf5-0b33-4819-a0e0-0354bfc36265 61 fields · synced Jul 12, 2026