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Disposable blood collection tubes

by Zhejiang RonMai Medical Technology Co., LTD

Ref Plain tube (No additive) 2mlModel Plain tube (No additive) Clot activator tube SST tube(Gel&Clot activator tube) Gel&Heparin Lithium Tube Gel&Heparin Sodium Tube 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 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR Number697848752RMDBCT4Y Basic UDI-DI 06978487520004UDI-DIDate4 Apr 2025RegisteredStatusActive

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  • Withdrawn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 blood collection tubes
Model / Reference
Plain tube (No additive) Clot activator tube SST tube(Gel&Clot activator tube) Gel&Heparin Lithium Tube Gel&Heparin Sodium Tube etc, Plain tube (No additive) 2ml
Primary DI / UDI-DI
06978487520004
Basic UDI-DI
697848752RMDBCT4Y
EMDN Code
W050101010201 Blood collection, tubes with additives or serum separator
Device Class
Class A
EU market of registration
Austria

Manufacturer details

EUDAMED SRN
CN-MF-000047207
Authorised representative
SUNGO Europe B.V. NL-AR-000000247

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