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Sonde de Sengstaken Blakemore en Silicone（Type 32）

by Create Medic Co., Ltd. 4 variants

Ref 800 320 0150

Active European Union

CE MDR

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/MDR Number4542187000068X Basic UDI-DI 04542187241310UDI-DIDate3 Jul 2025RegisteredStatusActive

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  • Withdrawn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/MDR Active

Specification

EUDAMED

Device Name
All Silicone Sengstaken Blakemore Tube
Model / Reference
800 320 0150
Primary DI / UDI-DI
04542187241310
Basic UDI-DI
4542187000068X
EMDN Code
G010201 Sengstaken tubes
Device Class
Class IIa
EU market of registration
France

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