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Novel Corona Virus (SARS-CoV-2) IgM/IgG Rapid Test Kit

EUDAMED

Class IVD General (EU MDR)

Ref SC30201W-20TRef SC30201W-50TRef SC30201W-25T

by Jiangsu Bioperfectus Technologies Co., Ltd.

Identity

Trade Name
Novel Corona Virus (SARS-CoV-2) IgM/IgG Rapid Test Kit EUDAMED
Novel Corona Virus (SARS-CoV-2) IgM/IgG Rapid Test Ki EUDAMED
Device Name
Novel Corona Virus (SARS-CoV-2) IgM/IgG Rapid Test Kit EUDAMED
Model / Reference
SC30201W-20T EUDAMED
SC30201W-50T EUDAMED
SC30201W-25T EUDAMED

Identifiers

Primary DI / UDI-DI
D-SC30201W-20TWE EUDAMED
D-SC30201W-50TWV EUDAMED
D-SC30201W-25TWV EUDAMED
Basic UDI-DI
B-SC30201W-20TWE EUDAMED
B-SC30201W-50TWV EUDAMED
B-SC30201W-25TWV EUDAMED
EMDN Code
W0105099099 VIROLOGY - RT & POC - OTHER EUDAMED

Classification

Device Class
Class IVD General EUDAMED
Market of Registration
Germany EUDAMED

Clinical & Handling

Sterile

No

EUDAMED

Human Tissues

No

EUDAMED

Animal Tissues

Yes

EUDAMED

Microbial Substances

Yes

EUDAMED

Reagent

Yes

EUDAMED

Self Testing

No

EUDAMED

Near-Patient Testing

Yes

EUDAMED

Professional Testing

Yes

EUDAMED

Companion Diagnostics

No

EUDAMED

Surgical Instrument

No

EUDAMED

Novel Corona Virus (SARS-CoV-2) IgM/IgG Rapid Test Kit by Jiangsu Bioperfectus Technologies 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 Bioperfectus Technologies Co., Ltd.
EUDAMED SRN
CN-MF-000014691
Authorised Representative
MedNet EC-REP GmbH DE-AR-000000002

Sources (3)

  • EUDAMED f618be0a-298a-446e-9b7d-35b973c4d854 61 fields · synced Jul 21, 2026
  • EUDAMED 2efcdd10-7766-45cc-bb09-b6c03c315534 61 fields · synced May 18, 2026
  • EUDAMED a3ca6d73-a9d7-4a8e-9f03-a22e8d77dff1 61 fields · synced May 19, 2026