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H-Seq-NGS Sequenzierungskit für 7x768 Typisierungen

by Institut für Klinische Transfusionsmedizin und Immungenetik Ulm gemeinnützige GmbH

Ref 014Model H-Seq-NGS, Ref 014

Active European Union

CE IVDR

Valid until

Not listed

EUDAMED holds no validity date

FDA recalls

Not applicable

No FDA record for this device

Documents

None linked in EUDAMED

A group certificate may exist

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, synced 24 Oct 2026. What this means

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR Number++G286HSeqNGSP9 Basic UDI-DI +G2860140ZUDI-DIDate21 Dec 2023RegisteredStatusActive

Certificates

0 certificates · EUDAMED

EUDAMED lists no certificate for this device's Basic UDI-DI.

A certificate issued for a device group may exist without being linked here.

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/IVDR Active

Specification

EUDAMED

Model / Reference
H-Seq-NGS, Ref 014, 014
Primary DI / UDI-DI
+G2860140Z
Basic UDI-DI
++G286HSeqNGSP9
Direct Marketing DI
+G2860140Z
EMDN Code
W0106010401 Hla-typing
Device Class
Class C
EU market of registration
Germany

Manufacturer details

EUDAMED SRN
DE-MF-000018980

Other devices from Institut für Klinische Transfusionsmedizin und Immungenetik Ulm gemeinnützige GmbH

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