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Wellgrow

by Shenzhen Wellgrow Biotech Co., Ltd. China EUDAMED

Ref 424101EModel 50T/Kit

EMDN W0103080199

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR Number697282550EZ51D64LW Basic UDI-DIDate18 Aug 2025RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Not covered

European Union — CE/IVDR Active

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 24 Oct 2026

Device Name
Hla-Dr
Model / Reference
50T/Kit, 424101E
Primary DI / UDI-DI
06972825503209
Basic UDI-DI
697282550EZ51D64LW
EMDN Code
W0103080199 Monoclonal antibodies for cell surface antigens - other
Device Class
Class A
Market of Registration
Austria

Manufacturer details

EUDAMED SRN
CN-MF-000022880
Authorised representative
SUNGO Europe B.V. NL-AR-000000247

Other devices from Shenzhen Wellgrow Biotech Co., Ltd.

See all devices from Shenzhen Wellgrow Biotech Co., Ltd. →

Properties & raw data

Show properties, registry sources and raw records
  • 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

Sources (1)

  • EUDAMED 562b4c2f-4ea9-48ee-ae9c-38bb9ea88ca7 61 fields · synced 24 Oct 2026