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COVID-19 & Influenza A+B Antigen Combo Rapid Test

EUDAMED

Class IVD devices for self-testing (EU MDR)

Ref FCO-6032HRef RQ007

by Safecare Biotech (hangzhou) Co., Ltd.

Identity

Trade Name
COVID-19 & Influenza A+B Antigen Combo Rapid Test EUDAMED
COVID-19/Influenza A+B Antigen Combo Rapid Test Kit(Colloidal gold method) EUDAMED
Device Name
COVID-19 & Influenza A+B Antigen Combo Rapid Test EUDAMED
COVID-19/Influenza A+B Antigen Combo Rapid Test Kit(Colloidal gold method) EUDAMED
Model / Reference
FCO-6032H EUDAMED
RQ007 EUDAMED

Identifiers

Primary DI / UDI-DI
06974246460284 EUDAMED
D-CNMF000054349RQ007MF EUDAMED
Basic UDI-DI
B-06974246460284 EUDAMED
B-CNMF000054349RQ007MF EUDAMED
EMDN Code
W0105090601 CORONAVIRUS / INFLUENZA - RT & POC EUDAMED
W0105070399 MULTIPLE VIRUSES - MULTIPLEX ASSAYS - OTHER EUDAMED

Classification

Device Class
Class IVD devices for self-testing EUDAMED
Class IVD General EUDAMED
Market of Registration
Germany EUDAMED

Clinical & Handling

Sterile

No

EUDAMED

Human Tissues

No

EUDAMED

Animal Tissues

Yes

EUDAMED

Microbial Substances

No

EUDAMED

Reagent

Yes

EUDAMED

Self Testing

Yes

EUDAMEDEUDAMED

Near-Patient Testing

No

EUDAMED

Professional Testing

No

EUDAMEDEUDAMED

Companion Diagnostics

No

EUDAMED

Surgical Instrument

No

EUDAMED

COVID-19 & Influenza A+B Antigen Combo Rapid Test by Safecare Biotech (Hangzhou) Co., Ltd. — Class IVD devices for self-testing — IVDD — listed in EUDAMED

Authorization Coverage (European Union — 27 member states)

Regulatory Authorizations

European Union Active

CE/IVDD

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Manufacturer

Manufacturer
Safecare Biotech (hangzhou) Co., Ltd.
EUDAMED SRN
CN-MF-000019109
Authorised Representative
Share info GmbH DE-AR-000005132

Sources (2)

  • EUDAMED 6d2ec297-3ffb-47fc-933e-1862eb9f51df 61 fields · synced Jul 23, 2026
  • EUDAMED 776c1492-58a5-4610-ad26-b4964fe8ecad 61 fields · synced Jul 23, 2026