Skip to content

Soft Biteblock

by Sion Biotext Medical Ltd. 4 variants

Ref 54D260-260003

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, self-declared

Class I: no certifier involved

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, synced 23 Oct 2026. What this means

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number729010142SBBFB Basic UDI-DI 07290108301908UDI-DIDate17 Jun 2026RegisteredStatusActive

Certificates

0 certificates · EUDAMED

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

Coverage

1 jurisdiction

SwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

European Union — CE/MDR Active

Specification

EUDAMED

Device Name
Soft Biteblock™
Model / Reference
54D260-260003
Primary DI / UDI-DI
07290108301908
Basic UDI-DI
729010142SBBFB
EMDN Code
G030804 Gastrointestinal endoscopy and echoendoscopy, bite blocks
Device Class
Class I
EU 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