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Tube products

by Hangzhou Agen Biotechnology Co Ltd EUDAMED

Active European Union

Ref SCT-500-SS-W-SModel MCT-0.6，MCT-0.6-L，T-005（MCT-150），T-005B（MCT-150），T-008，T-001，T-002，CT-1.5，CT-1.5-L，CT-1.5-B，CT-1.5-Y，CT-1.5-V，CT-1.5-P，CT-1.5-G，CT-1.5-O，CT-1.5-M，CT-2.0, etc

Regulatory status

as of 26 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR Number697900604TT001HZ Basic UDI-DIDate8 Oct 2025RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not known
  • Not covered

European Union — CE/IVDR Active

Certificates: none listed in EUDAMED

Specification

EUDAMED

Device Name
Tube products
Model / Reference
MCT-0.6，MCT-0.6-L，T-005（MCT-150），T-005B（MCT-150），T-008，T-001，T-002，CT-1.5，CT-1.5-L，CT-1.5-B，CT-1.5-Y，CT-1.5-V，CT-1.5-P，CT-1.5-G，CT-1.5-O，CT-1.5-M，CT-2.0, etc, SCT-500-SS-W-S
Primary DI / UDI-DI
06979006041130
Market of Registration
Austria

Manufacturer details

EUDAMED SRN
CN-MF-000049623
Authorised representative
SUNGO Europe B.V. NL-AR-000000247

Other devices from Hangzhou Agen Biotechnology Co Ltd

See all devices from Hangzhou Agen Biotechnology Co Ltd →

Properties & raw data

Show properties, registry sources and raw records
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

Sources (1)

  • EUDAMED 24bac5ae-a7d8-4d24-8b06-fed60484423e 61 fields · synced 25 Oct 2026