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Sample Collection Kit

by Huachenyang (Shenzhen) Technology Co., Ltd. 6 variants

Ref CY-93050R-TSModel CY-90001T,CY-93050T,CY-93050TS,CY-93050RT,CY-96000T,CY-98000TS,CY-F1-10,CY-90003T-Stuart,CY-90003T-Amies,CY-90003T-Cary Blair,CY-F005-10,CY-93050AM,CY-90002T,CY-95000BM,CY98000T, etc

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 24 Oct 2026. What this means

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR Number697448899CY-F0/0/5/2/3V7J Basic UDI-DI 06974488992345UDI-DIDate16 Apr 2026RegisteredStatusActive

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  • Withdrawn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

Model / Reference
CY-90001T, CY-93050T, CY-93050TS, CY-93050RT, CY-96000T, CY-98000TS, CY-F1-10, CY-90003T-Stuart, CY-90003T-Amies, CY-90003T-Cary Blair, CY-F005-10, CY-93050AM, CY-90002T, CY-95000BM, CY98000T, etc, CY-93050R-TS
Primary DI / UDI-DI
06974488992345
Basic UDI-DI
697448899CY-F0/0/5/2/3V7J
EMDN Code
W05019099 Samples collection devices - other
Device Class
Class A
EU market of registration
Spain

Manufacturer details

EUDAMED SRN
CN-MF-000020236
Authorised representative
SUNGO Europe B.V. NL-AR-000000247

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Properties

  • Reagent

Other properties (10)

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