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BONASTENT® Colo-Rectal Covered

by Sewoon Medical Co., Ltd.

Ref BCC-200814

Active European Union

CE AIMDD

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 25 Oct 2026. What this means

Regulatory status

as of registry sync 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/AIMDD NumberB-08806369465083 Basic UDI-DI 08806369465083UDI-DIDate6 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  • Withdrawn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/AIMDD Active

Specification

EUDAMED

Device Name
Sterile Single-use Colo-rectal Stent
Model / Reference
BCC-200814
Primary DI / UDI-DI
08806369465083
Basic UDI-DI
B-08806369465083
EMDN Code
P0503 Colonic and duodenal prostheses
Device Class
Class AIMDD
EU market of registration
Belgium

Manufacturer details

EUDAMED SRN
KR-MF-000019142
Authorised representative
Obelis s.a. BE-AR-000000106

Other devices from Sewoon Medical Co., Ltd.

See all devices from Sewoon Medical Co., Ltd. →

Properties

  • Sterile
  • Implantable

Other properties (9)

  • Reusable: No
  • Contains Latex: No
  • Reprocessed: No
  • Human-derived: No
  • Human Tissues: No
  • Animal Tissues: No
  • Administering Medicine: No
  • Measuring Function: No
  • Incorporates Medicinal Product: No