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SARS-Cov-2＆Influenza A＆B Combo Rapid Test Cassette (swab)

EUDAMED

Class IVD General (EU MDR)

Ref A231301DRef K751416DRef K541416D

by Hangzhou Cybereagen Biotech Co., Ltd.

Identity

Trade Name
SARS-Cov-2＆Influenza A＆B Combo Rapid Test Cassette (swab) EUDAMED
SARS-Cov-2＆Influenza A/B Combo Rapid Test Cassette (swab) EUDAMED
Device Name
SARS-Cov-2＆Influenza A＆B Combo Rapid Test Cassette (swab) EUDAMED
Model / Reference
A231301D EUDAMED
K751416D EUDAMED
K541416D EUDAMED

Identifiers

Primary DI / UDI-DI
06976753473313 EUDAMED
06971792050129 EUDAMED
06971792050501 EUDAMED
Basic UDI-DI
B-06976753473313 EUDAMED
B-06971792050129 EUDAMED
B-06971792050501 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

SARS-Cov-2＆Influenza A＆B Combo Rapid Test Cassette (swab) 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 59a2e0dc-d5ee-47ec-a07b-0249123f0acd 61 fields · synced Oct 6, 2026
  • EUDAMED b09be0e3-3bde-4771-acc3-645119f41efa 61 fields · synced May 17, 2026
  • EUDAMED 3c734dea-56e3-4630-89a6-ab97c66d4ac3 61 fields · synced May 19, 2026