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Immunochromogenic Reagent

by Xiamen Talent Biomedical Technology Co., Ltd 10 variants

Ref 600 TestsModel 1100 Tests, 300 Tests, 600 Tests

Active European Union

CE IVDR CE IVDD

Valid until

Not listed

EUDAMED holds no validity date

FDA recalls

Not applicable

No FDA record for this device

Documents

None, self-declared

Class I: no certifier involved

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR NumberB-06937455441550 Basic UDI-DI Date14 Aug 2025RegisteredStatusActive
European UnionCE/IVDD NumberB-06937455441550 Basic UDI-DI Date14 Aug 2025RegisteredStatusActive

Certificates

0 certificates · EUDAMED

No certifier certificate is listed. Devices of this class are self-declared by the manufacturer.

Coverage

1 jurisdiction

SwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

European Union — CE/IVDR, CE/IVDD Active

Specification

EUDAMED

Device Name
Immunochromogenic Reagent
Model / Reference
1100 Tests, 600 Tests, 300 Tests
Primary DI / UDI-DI
06937455441550, 06937455441543, 06937455440157, 16977376430049
Basic UDI-DI
B-06937455441550, B-06937455441543, B-06937455440157, 697737643DD23MY
EMDN Code
W01030711, W01029099
Device Class
Class IVD General
Class A
EU 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

  • Reagent
  • Professional Testing

Other properties (9)

  • Sterile: No
  • Human Tissues: No
  • Animal Tissues: No
  • Microbial Substances: No
  • Self Testing: No
  • Near-Patient Testing: No
  • Companion Diagnostics: No
  • Surgical Instrument: No
  • New Device: No