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All Silicone Sengstaken Blakemore Tube (Type 32, W/O Stylet)

by Create Medic Co., Ltd. Japan EUDAMED

Ref 800 001 7197

EMDN G010201

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number4542187000068X Basic UDI-DIDate3 Jul 2025RegisteredStatusWithdrawn Not intended for the EU market

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Withdrawn
  • Not covered

European Union — CE/MDR Withdrawn

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 24 Oct 2026

Device Name
All Silicone Sengstaken Blakemore Tube
Model / Reference
800 001 7197
Primary DI / UDI-DI
04542187228632
Basic UDI-DI
4542187000068X
EMDN Code
G010201 Sengstaken tubes
Device Class
Class IIa

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 & raw data

Show properties, registry sources and raw records
  • 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

Sources (1)

  • EUDAMED 75f061c0-b2ea-40ad-8e4d-f5887cf285fd 61 fields · synced 24 Oct 2026