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Biliary Dilator

by Shaili Endoscopy 14 variants

Ref 46Model S-BD-7, S-BD-8.5, S-BD-10, S-BD-11.5, S-BD-7-DBE, S-BD-8.5-DBE, S-BD-10-DBE, S-BD-11.5-DBE, S-BD-5, S-BD-5-DBE, S-BD-9, S-BD-6-DBE, S-BD-9- DBE, S-BD-6

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 Number89041742SEBID027UT Basic UDI-DI 08904174221037UDI-DIDate8 Oct 2026RegisteredStatusActive

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  • Withdrawn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
Biliary Dilator
Model / Reference
S-BD-7, S-BD-8.5, S-BD-10, S-BD-11.5, S-BD-7-DBE, S-BD-8.5-DBE, S-BD-10-DBE, S-BD-11.5-DBE, S-BD-5, S-BD-5-DBE, S-BD-9, S-BD-6-DBE, S-BD-9- DBE, S-BD-6, 46
Primary DI / UDI-DI
08904174221037
Basic UDI-DI
89041742SEBID027UT
EMDN Code
G0399 Digestive endoscopy devices - other
Device Class
Class IIa
EU market of registration
Germany

Manufacturer details

EUDAMED SRN
IN-MF-000020990
Authorised representative
Obelis s.a. BE-AR-000000106

Other devices from Shaili Endoscopy

See all devices from Shaili Endoscopy →

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