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Sengstaken-Blakemore Tube (Type-42)

by Create Medic Co., Ltd. EUDAMED

Active European Union

Ref 002-182-0400

Regulatory status

as of 27 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number4542187000068X Basic UDI-DIDate3 Jul 2025RegisteredStatusActive

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/MDR Active

Certificates: none listed in EUDAMED

Specification

EUDAMED

Device Name
All Silicone Sengstaken Blakemore Tube
Model / Reference
002-182-0400
Primary DI / UDI-DI
04542187198232
Basic UDI-DI
4542187000068X
EMDN Code
G010201 Sengstaken tubes
Device Class
Class IIa
Market of Registration
Netherlands

Manufacturer details

EUDAMED SRN
JP-MF-000010849
Authorised representative
MDSS GmbH DE-AR-000005430

Other devices from Create Medic Co., Ltd.

See all devices from Create Medic Co., Ltd. →

Properties

  • Sterile

Other properties (12)

  • 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