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NIBP Cuff

by Contec Medical Systems Co., Ltd. EUDAMED

Active European Union

Ref IGN0084Model I Series

Regulatory status

as of 28 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number69450401IGNYH Basic UDI-DIDate10 Jan 2025RegisteredStatusActive

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/MDR Active

Certificates

0 certificates · EUDAMED

No notified-body certificate is listed. Devices of this class are self-declared by the manufacturer.

Specification

EUDAMED

Model / Reference
I Series, IGN0084
Primary DI / UDI-DI
06945040109181
Basic UDI-DI
69450401IGNYH
Direct Marketing DI
06945040109181
EMDN Code
Z12040180 General medicine diagnosis and monitoring instruments - hardware accessories
Device Class
Class I
Market of Registration
Italy

Manufacturer details

EUDAMED SRN
CN-MF-000007715
Authorised representative
Prolinx GmbH DE-AR-000005129

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Properties

Other properties (13)

  • Sterile: No
  • Implantable: No
  • Reusable: No
  • Contains Latex: No
  • Reprocessed: No
  • CMR Substance: No
  • Human-derived: No
  • Human Tissues: No
  • Animal Tissues: No
  • Endocrine Disruptor: No
  • Administering Medicine: No
  • Measuring Function: No
  • Incorporates Medicinal Product: No