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Novel Coronavirus (SARS-Cov-2) Antigen Rapid Test Device (saliva)

EUDAMED

Class IVD General (EU MDR)

Ref A220201DRef K590516DRef K700516D

by Hangzhou Cybereagen Biotech Co., Ltd.

Identity

Trade Name
Novel Coronavirus (SARS-Cov-2) Antigen Rapid Test Device (saliva) EUDAMED
Novel Coronavirus（SARS-Cov-2）Antigen Rapid Test Device（saliva） EUDAMED
Device Name
Novel Coronavirus（SARS-Cov-2）Antigen Rapid Test Device（saliva） EUDAMED
Model / Reference
A220201D EUDAMED
K590516D EUDAMED
K700516D EUDAMED

Identifiers

Primary DI / UDI-DI
06976753473283 EUDAMED
06971792050051 EUDAMED
06971792050624 EUDAMED
Basic UDI-DI
B-06976753473283 EUDAMED
B-06971792050051 EUDAMED
B-06971792050624 EUDAMED
EMDN Code
W0105040619 EUDAMED

Classification

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

Clinical & Handling

Sterile

No

EUDAMED

Human Tissues

No

EUDAMED

Animal Tissues

No

EUDAMED

Microbial Substances

No

EUDAMED

Reagent

Yes

EUDAMED

Self Testing

No

EUDAMEDEUDAMED

Near-Patient Testing

No

EUDAMED

Professional Testing

Yes

EUDAMEDEUDAMED

Companion Diagnostics

No

EUDAMED

Surgical Instrument

No

EUDAMED

Novel Coronavirus (SARS-Cov-2) Antigen Rapid Test Device (saliva) by Hangzhou Cybereagen Biotech 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
Hangzhou Cybereagen Biotech Co., Ltd.
EUDAMED SRN
CN-MF-000037850
Authorised Representative
CMC Medical Devices & Drugs SL ES-AR-000000293

Sources (3)

  • EUDAMED 935895ec-c53a-4629-a41a-153b8e56ec1d 61 fields · synced Oct 6, 2026
  • EUDAMED bc7e9acb-5bda-4f70-91e9-cbb039bf716a 61 fields · synced May 17, 2026
  • EUDAMED 01cdb1c4-b937-4486-bda7-20deb5c8443c 61 fields · synced May 18, 2026