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EBER ISH Kit

by Xiamen Talent Biomedical Technology Co., Ltd China EUDAMED

Ref CISH-EBER-200QModel II\ 200 Tests

EMDN W01030709

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDD NumberB-06937455448641 Basic UDI-DIDate13 May 2026RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Expiring (legacy directive)
  • Not covered

European Union — CE/IVDD Expiring (legacy directive)

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 23 Oct 2026

Model / Reference
II\ 200 Tests, CISH-EBER-200Q
Primary DI / UDI-DI
06937455448641
Basic UDI-DI
B-06937455448641
EMDN Code
W01030709 Primary antisera for immunohistology
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

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
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 356691ff-d185-4b00-a615-6da27e57f2e9 61 fields · synced 23 Oct 2026