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FlashDx Shenzhen Inc

Active in EUDAMED

Chinafrom SRN EUDAMED SRN CN-MF-000025748

Devices
14
Registrations
EUDAMED

At a glance

Counted by deviCERTS from registry records

Market reach

European Union
EUDAMED actor

Catalogue14

Newest first, rows 1-14 of 14

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  • SARS-CoV-2 Test Ref CoV2-10

    Active Regimes: CE IVDD Registry: EUDAMED Class:IVD General

  • Automated Nucleic Acid Detection System Ref FlashDx-1000-E

    Active Regimes: CE IVDR Registry: EUDAMED Class:A

  • Respiratory Panel 1.1 Ref RP-P10-10

    Active Regimes: CE IVDD Registry: EUDAMED Class:IVD General

  • Automated PCR Analysis System Ref FlashDx® sSPRT™ 12T

    Active Regimes: CE IVDR Registry: EUDAMED Class:A

  • MRSA/SA Test Ref MARSA-10

    Active Regimes: CE IVDD Registry: EUDAMED Class:IVD General

  • CRE Test Ref CRE-P5-10

    Active Regimes: CE IVDD Registry: EUDAMED Class:IVD General

  • Respiratory Panel 1.0 Ref RP1-P10-10

    Active Regimes: CE IVDD Registry: EUDAMED Class:IVD General

  • SARS-CoV-2/FluA/FluB/RSV Test Ref Cov2P4-10

    Active Regimes: CE IVDD Registry: EUDAMED Class:IVD General

  • GBS Test Ref GBS-P1-10

    Active Regimes: CE IVDD Registry: EUDAMED Class:IVD General

  • SARS-CoV-2 Test Ref CoV2-20

    Active Regimes: CE IVDD Registry: EUDAMED Class:IVD General

  • Arbovirus Panel (ENA) Ref ABVP8E-10

    Active Regimes: CE IVDD Registry: EUDAMED Class:IVD General

  • Respiratory Panel 2 Ref RP2-P7-10

    Active Regimes: CE IVDD Registry: EUDAMED Class:IVD General

  • Automated PCR Analysis System Ref FlashDx® sSPRT™ 8T

    Active Regimes: CE IVDR Registry: EUDAMED Class:A

  • Automated PCR Analysis System Ref FlashDx® sSPRT™ 4T

    Active Regimes: CE IVDR Registry: EUDAMED Class:A

Rows 1-14 of 14

Company details

EUDAMED SRN
CN-MF-000025748
EUDAMED status
Active
EUDAMED registered name
FlashDx Shenzhen Inc
EUDAMED abbreviated name
FlashDx
Registered address
China Merchants GuangMing Science Park,, Suite C705, Building A3；Suite 4C, Building B6 & Suite A201, Building B5, 518000, Shenzhen, China
PRRC contact
Feng Zhang(public in EUDAMED)

Frequently asked questions

How many devices does FlashDx Shenzhen Inc have in the registry?

The registry currently lists 14 devices for FlashDx Shenzhen Inc. Devices recorded under merged duplicate company entries are counted once.

Which registries list FlashDx Shenzhen Inc's devices?

Among its 14 most recently registered devices, FlashDx Shenzhen Inc has devices listed in EUDAMED (14 devices).

What risk classes do FlashDx Shenzhen Inc's devices fall under?

Among its 14 most recently registered devices, the classes recorded for FlashDx Shenzhen Inc's devices are IVDR Class A and IVD general. Each device page shows its own class and authorisation.

What are the newest devices from FlashDx Shenzhen Inc in the registry?

The most recently registered devices listed for FlashDx Shenzhen Inc include SARS-CoV-2 Test, Automated Nucleic Acid Detection System, Respiratory Panel 1.1 and Automated PCR Analysis System.

Generated automatically from registry data and not verified by a human reviewer.