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HemoTypeSC

by Silver Lake Research Corporation United States EUDAMED

Ref HT111

EMDN W0106010109

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDD NumberB-00850031753020 Basic UDI-DIDate22 May 2023RegisteredStatusActive

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 22 Oct 2026

Device Name
HemoTypeSC™ Test Kit – In Vitro Diagnostic – Pack of 50 Tests
Model / Reference
HT111
Primary DI / UDI-DI
00850031753020
Basic UDI-DI
B-00850031753020
EMDN Code
W0106010109 Sickle cell anemia
Device Class
Class IVD General
Market of Registration
Germany

Manufacturer details

EUDAMED SRN
US-MF-000027373
Authorised representative
Emergo Europe B.V. NL-AR-000000116

Other devices from Silver Lake Research Corporation

Properties & raw data

Show properties, registry sources and raw records
  • Human Tissues
  • Animal Tissues
  • Near-Patient Testing
  • Professional Testing
Other properties (6)
  • Sterile: No
  • Microbial Substances: No
  • Reagent: No
  • Self Testing: No
  • Companion Diagnostics: No
  • Surgical Instrument: No

Sources (1)

  • EUDAMED 245042be-05db-40bf-9af4-1e255e6d84a3 61 fields · synced 22 Oct 2026