Skip to content

Cryotube

by Shanghai AvanTech BioSciences Co., Ltd

Ref ICT-200S-RModel ICT-200S-R、ICT-200S-G、ICT-200S-Y、ICT-200S-W、ICT-200S-V、ICT-200S-B、ECT-160S-R、ECT-160S-G、ECT-160S-Y、ECT-160S-W、ECT-160S-V、ECT-160S-B、ECT-050-R、ECT-050-G、ECT-050-Y、ECT-050-W、ECT-050-B、ECT-150-R、ECT-150-G、ECT-150-Y, 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 Number697531306CT001AR Basic UDI-DI 06975313060017UDI-DIDate14 Aug 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  • Withdrawn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
Cryotube
Model / Reference
ICT-200S-R、ICT-200S-G、ICT-200S-Y、ICT-200S-W、ICT-200S-V、ICT-200S-B、ECT-160S-R、ECT-160S-G、ECT-160S-Y、ECT-160S-W、ECT-160S-V、ECT-160S-B、ECT-050-R、ECT-050-G、ECT-050-Y、ECT-050-W、ECT-050-B、ECT-150-R、ECT-150-G、ECT-150-Y, etc., ICT-200S-R
Primary DI / UDI-DI
06975313060017
Basic UDI-DI
697531306CT001AR
EMDN Code
W0599 IVD general use consumable devices - other
Device Class
Class A
EU market of registration
Austria

Manufacturer details

EUDAMED SRN
CN-MF-000026005
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