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Immunochromogenic Reagent

by Xiamen Talent Biomedical Technology Co., Ltd China EUDAMED

Ref DD43-600Model 300 Tests, 600 Tests

EMDN W01029099

Regulatory status

as of 24 Oct 2026

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

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Not covered

European Union — CE/IVDR Active

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 22 Oct 2026

Device Name
Immunochromogenic Reagent
Model / Reference
300 Tests, 600 Tests, DD43-600
Primary DI / UDI-DI
06937455448658
Basic UDI-DI
697737643DD23MY
Direct Marketing DI
06937455448658
EMDN Code
W01029099 Immunochemistry reagents - other
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

See all devices from Xiamen Talent Biomedical Technology Co., Ltd →

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 42979176-3e90-4d50-88bb-197a4bd70522 61 fields · synced 22 Oct 2026