Skip to content

Soft BiteBlock

by Sion Biotext Medical Ltd. EUDAMED

Active European Union

Ref 54D260-260000

Regulatory status

as of 29 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number729010142SBBFB Basic UDI-DIDate17 Jun 2026RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • 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

Device Name
Soft Biteblock™
Model / Reference
54D260-260000
Primary DI / UDI-DI
07290108301892
Basic UDI-DI
729010142SBBFB
EMDN Code
G030804 Gastrointestinal endoscopy and echoendoscopy, bite blocks
Device Class
Class I
Market of Registration
Netherlands

Manufacturer details

EUDAMED SRN
IL-MF-000012169
Authorised representative
Emergo Europe B.V. NL-AR-000000116

Other devices from Sion Biotext Medical Ltd

See all devices from Sion Biotext Medical Ltd →

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