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Specimen Transport Medium

by Jiangsu HanHeng Medical Technology Co., Ltd. 7 variants

Ref HPV-2mL, TCT-2mL, TCT-12mL, HPV-8mL, HPV-12mL, TCT-5mL, HPV-5mL, TCT-3mL, TCT-20mL, HPV-20mLModel HPV-2mL, HPV-3mL, HPV-5mL, HPV-8mL, HPV-10mL, HPV-12mL, HPV-15mL, HPV-20mL, TCT-2mL, TCT-3mL, TCT-5mL, TCT-8mL, TCT-10mL, TCT-12mL, TCT-15mL, TCT-20mL

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 Number697369781876SX Basic UDI-DI Date2 Jun 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  • Withdrawn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
Specimen Transport Medium
Model / Reference
HPV-2mL, HPV-3mL, HPV-5mL, HPV-8mL, HPV-10mL, HPV-12mL, HPV-15mL, HPV-20mL, TCT-2mL, TCT-3mL, TCT-5mL, TCT-8mL, TCT-10mL, TCT-12mL, TCT-15mL, TCT-20mL
Primary DI / UDI-DI
06973697818767, 06973697818842, 06973697818897, 06973697818798, 06973697818811, 06973697818866, 06973697818781, 06973697818859, 06973697818910, 06973697818835
Basic UDI-DI
697369781876SX, 697369781884SW
EMDN Code
W05020199 Samples transport, containers - other
Device Class
Class A
EU market of registration
Netherlands

Manufacturer details

EUDAMED SRN
CN-MF-000023013
Authorised representative
SUNGO Europe B.V. NL-AR-000000247

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Properties

  • Reagent
  • Professional Testing

Other properties (9)

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