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Immunochromogenic Reagent

by Xiamen Talent Biomedical Technology Co., Ltd China EUDAMED

Ref 50ml

EMDN W01030711

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR NumberB-06937455440102 Basic UDI-DIDate14 Aug 2025RegisteredStatusActive

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
50ml
Primary DI / UDI-DI
06937455440102, 06937455441499
Basic UDI-DI
B-06937455440102, B-06937455441499
EMDN Code
W01030711 Immunohistology kits
Device Class
Class IVD General
Market of Registration
Austria

Manufacturer details

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

Related devices

Category: Immunohistochemistry antibody detection IVD, kit, enzyme immunohistochemistry

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
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 (2)

  • EUDAMED 74492c76-5d58-42a3-803f-d6277d644762 61 fields · synced 22 Oct 2026
  • EUDAMED 7c286965-ca59-44a4-b04d-d4ed64abd2b0 61 fields · synced 18 May 2026