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Disposable Virus Sampling Kit(B3) 25tests/kit

by Zhuhai Lituo Biotechnology Co., Ltd.

Ref 119Model 25tests/kit，50tests/kit

Active European Union

CE IVDR

Valid until

Not listed

EUDAMED holds no validity date

FDA recalls

Not applicable

No FDA record for this device

Documents

None, self-declared

Class I: no certifier involved

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR Number697223584DSVK00001GV Basic UDI-DI 06972235841199UDI-DIDate21 Feb 2023RegisteredStatusActive

Certificates

0 certificates · EUDAMED

No certifier certificate is listed. Devices of this class are self-declared by the manufacturer.

Coverage

1 jurisdiction

SwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

European Union — CE/IVDR Active

Specification

EUDAMED

Device Name
Disposable Virus Sampling Kit
Model / Reference
25tests/kit，50tests/kit, 119
Primary DI / UDI-DI
06972235841199
Basic UDI-DI
697223584DSVK00001GV
EMDN Code
W05019099 Samples collection devices - other
Device Class
Class A
EU market of registration
Türkiye

Manufacturer details

EUDAMED SRN
CN-MF-000026852
Authorised representative
CMC Medical Devices & Drugs SL ES-AR-000000293

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Properties

  • Professional Testing

Other properties (10)

  • Sterile: No
  • Human Tissues: No
  • Animal Tissues: No
  • Microbial Substances: No
  • Reagent: No
  • Self Testing: No
  • Near-Patient Testing: No
  • Companion Diagnostics: No
  • Surgical Instrument: No
  • New Device: No