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Multi Respiratory Pathogen Real Time PCR Detection Kit

EUDAMED

Class IVD General (EU MDR)

Ref R23103C2024 Ref R23102T2024 Ref R23203T2012Ref R23104C2024

by Jiangsu Mole Bioscience Co., LTD.

Identity

Device Name
Multi Respiratory Pathogen Real Time PCR Detection Kit EUDAMED
Model / Reference
R23103C2024 EUDAMED
R23102T2024 EUDAMED
R23203T2012 EUDAMED
R23104C2024 EUDAMED

Identifiers

Primary DI / UDI-DI
06970895475730 EUDAMED
06970895475525 EUDAMED
06970895475907 EUDAMED
06970895475747 EUDAMED
Basic UDI-DI
B-06970895475730 EUDAMED
B-06970895475525 EUDAMED
B-06970895475907 EUDAMED
B-06970895475747 EUDAMED
EMDN Code
W0105070503 RESPIRATORY TRACT INFECTIONS - MULTIPLEX NA REAGENTS EUDAMED

Classification

Device Class
Class IVD General EUDAMED
Market of Registration
Spain EUDAMED
Greece 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

Multi Respiratory Pathogen Real Time PCR Detection Kit by Jiangsu Mole Bioscience Co., LTD. — Class IVD General — IVDD — listed in EUDAMED

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
Medunion S.L. ES-AR-000019366

Sources (4)

  • EUDAMED 036c54b2-20d2-45fe-b6c4-bdc85eb86d48 61 fields · synced Jul 14, 2026
  • EUDAMED eddd37b9-581f-42c9-b857-a10633df99a4 61 fields · synced May 17, 2026
  • EUDAMED f353f3e2-6ff8-40d8-98bd-61ae7713e850 61 fields · synced May 17, 2026
  • EUDAMED c7ecf217-2bb9-4544-8e66-53fe94ad38ad 61 fields · synced May 18, 2026