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TEG 6s QC Level 1

by Haemonetics S.A. EUDAMED

Active European Union

Ref 07-650

Regulatory status

as of 27 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR Number081274701TEG60043V Basic UDI-DIDate11 Sep 2026RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not known
  • Not covered

European Union — CE/IVDR Active

Certificates: none listed in EUDAMED

Specification

EUDAMED

Device Name
QC Level 1
Model / Reference
07-650
Primary DI / UDI-DI
10812747018227
Basic UDI-DI
081274701TEG60043V
EMDN Code
W0103020799 Haemostasis controls - other
Device Class
Class A
Market of Registration
Germany

Manufacturer details

EUDAMED SRN
CH-MF-000034549
Authorised representative
Haemonetics Italia s.r.l IT-AR-000021067

Other devices from Haemonetics S.A.

See all devices from Haemonetics S.A. →

Properties

  • Animal Tissues
  • Reagent
  • Near-Patient Testing
  • Professional Testing

Other properties (7)

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