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Newborn Screening Specimen Collection Paper

by Tianjin Geneally Biotechnology Co., Ltd China EUDAMED

Ref model D:IndicatingModel model A: Dried Blood Spot Collection model B: Protein Saver model C: Inactivated and Storage model D: Indicating

EMDN W050101010101

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR Number697770622NSSCPV9 Basic UDI-DIDate10 Sep 2024RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Not covered

European Union — CE/IVDR Active

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 23 Oct 2026

Device Name
Newborn Screening Specimen Collection Paper
Model / Reference
model A: Dried Blood Spot Collection model B: Protein Saver model C: Inactivated and Storage model D: Indicating, model D:Indicating
Primary DI / UDI-DI
06977706220039
Basic UDI-DI
697770622NSSCPV9
EMDN Code
W050101010101 Blood collection, closed syringes with additives
Device Class
Class A
Market of Registration
Italy

Manufacturer details

EUDAMED SRN
CN-MF-000043699
Authorised representative
SUNGO Europe B.V. NL-AR-000000247

Other devices from Tianjin Geneally Biotechnology Co., Ltd

Properties & raw data

Show properties, registry sources and raw records
  • Professional Testing
Other properties (10)
  • Sterile: No
  • Human Tissues: No
  • Animal Tissues: No
  • Microbial Substances: No
  • Reagent: No
  • Self Testing: No
  • Near-Patient Testing: No
  • Companion Diagnostics: No
  • Surgical Instrument: No
  • New Device: No

Sources (1)

  • EUDAMED b75641d7-f525-4e48-a3ac-c5e013258f3b 61 fields · synced 23 Oct 2026