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Blood Collection tube

by Nantong Huayun Medical Equipment Technology Co., Ltd.

Ref Micro tube 0.5mlModel Micro tube 0.5ml-1ml PET/Glass- Vacuum tube (1-10ml) PP/Non-Vacuum Tube (1-10ml) (Plain/ETDA K2/ETDA K3/Clot activator/ Gel and Clot Activator/Glucose/Lithium Heparin/Sodium Heparin/ESR tube/PT tube)

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 Number697818678HYBCTYG Basic UDI-DI 06978186781133UDI-DIDate14 Jul 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  • Withdrawn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

Device Name
Blood Collection tube
Model / Reference
Micro tube 0.5ml-1ml PET/Glass- Vacuum tube (1-10ml) PP/Non-Vacuum Tube (1-10ml) (Plain/ETDA K2/ETDA K3/Clot activator/ Gel and Clot Activator/Glucose/Lithium Heparin/Sodium Heparin/ESR tube/PT tube), Micro tube 0.5ml
Primary DI / UDI-DI
06978186781133
Basic UDI-DI
697818678HYBCTYG
EMDN Code
W0599 IVD general use consumable devices - other
Device Class
Class A
EU market of registration
Austria

Manufacturer details

EUDAMED SRN
CN-MF-000037480
Authorised representative
SUNGO Europe B.V. NL-AR-000000247

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Properties

Other properties (11)

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