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Immunochromogenic Reagent

by Xiamen Talent Biomedical Technology Co., Ltd China EUDAMED

Ref DD43-300Model 300 Tests, 600 Tests EMDN W01029099,W01030709

Regulatory status

as of 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR Number697737643DD23MY Basic UDI-DIDate28 May 2024RegisteredStatusActive

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  • Withdrawn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 · synced 25 Oct 2026

Device Name
Immunochromogenic Reagent
Model / Reference
300 Tests, 600 Tests, DD43-300
Primary DI / UDI-DI
06937455448603
Basic UDI-DI
697737643DD23MY
Direct Marketing DI
06937455448603
EMDN Code
W01029099,W01030709
Device Class
Class A
Market of Registration
Austria

Manufacturer details

EUDAMED SRN
CN-MF-000039397
Authorised representative
SUNGO Europe B.V. NL-AR-000000247

Other devices from Xiamen Talent Biomedical Technology Co., Ltd

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Properties & raw data

Show properties, registry sources and raw records
  • Reagent
  • Professional Testing
  • New Device
Other properties (8)
  • Sterile: No
  • Human Tissues: No
  • Animal Tissues: No
  • Microbial Substances: No
  • Self Testing: No
  • Near-Patient Testing: No
  • Companion Diagnostics: No
  • Surgical Instrument: No

Sources (1)

  • EUDAMED 06937455448603|697737643DD23MY 61 fields · synced 25 Oct 2026