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Gastrointestinal and Biliary Balloon Catheters

by Jiangsu Vedkang Medical Science and Technology Co., Ltd. 56 variants

Ref VDK-BD-16-80-180, VDK-BD-16-60-110, VDK-BD-35-80-90, VDK-BD-10-40-90, VDK-BD-12-40-90, VDK-BD-12-60-180, VDK-BD-14-80-180, VDK-BD-08-30-180, VDK-BD-14-60-110, VDK-BD-16-60-180, VDK-BD-08-30-90, VDK-BD-25-80-110, VDK-BD-18-60-90, VDK-BD-16-80-230, VDK-BD-08-30-110, VDK-BD-08-40-200, VDK-BD-06-40-240, VDK-BD-20-80-230, VDK-BD-16-80-250, VDK-BD-06-30-90, VDK-BD-14-40-120, VDK-BD-10-40-230, VDK-BD-18-80-250, VDK-BD-12-60-200, VDK-BD-14-60-180, VDK-BD-35-80-120, VDK-BD-06-40-200, VDK-BD-14-40-200, VDK-BD-08-40-180, VDK-BD-20-60-180, VDK-BD-10-40-180, VDK-BD-16-60-90, VDK-BD-10-40-250, VDK-BD-12-80-180, VDK-BD-10-40-200, VDK-BD-35-80-110, VDK-RBD-10/11/12-60-200, VDK-RBD-08-40-200, VDK-RBD-6/7/8-60-180, VDK-RBD-08-30-200, VDK-RBD-08-30-180, VDK-RBD-18/19/20-80-180, VDK-RBD-15/16.5/18-80-200, VDK-RBD-06-40-180, VDK-RBD-10/11/12-40-180, VDK-RBD-06-30-200, VDK-RBD-12/13.5/15-60-200, VDK-RBD-8/9/10-60-200, VDK-RBD-6/7/8-60-200

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 Number697005757029HU Basic UDI-DI Date9 Apr 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  • Withdrawn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

Model / Reference
VDK-BD-16-80-180, VDK-BD-16-60-110, VDK-BD-35-80-90, VDK-BD-10-40-90, VDK-BD-12-40-90, VDK-BD-12-60-180, VDK-BD-14-80-180, VDK-BD-08-30-180, VDK-BD-14-60-110, VDK-BD-16-60-180, VDK-BD-08-30-90, VDK-BD-25-80-110, VDK-BD-18-60-90, VDK-BD-16-80-230, VDK-BD-08-30-110, VDK-BD-08-40-200, VDK-BD-06-40-240, VDK-BD-20-80-230, VDK-BD-16-80-250, VDK-BD-06-30-90, VDK-BD-14-40-120, VDK-BD-10-40-230, VDK-BD-18-80-250, VDK-BD-12-60-200, VDK-BD-14-60-180, VDK-BD-35-80-120, VDK-BD-06-40-200, VDK-BD-14-40-200, VDK-BD-08-40-180, VDK-BD-20-60-180, VDK-BD-10-40-180, VDK-BD-16-60-90, VDK-BD-10-40-250, VDK-BD-12-80-180, VDK-BD-10-40-200, VDK-BD-35-80-110, VDK-RBD-10/11/12-60-200, VDK-RBD-08-40-200, VDK-RBD-6/7/8-60-180, VDK-RBD-08-30-200, VDK-RBD-08-30-180, VDK-RBD-18/19/20-80-180, VDK-RBD-15/16.5/18-80-200, VDK-RBD-06-40-180, VDK-RBD-10/11/12-40-180, VDK-RBD-06-30-200, VDK-RBD-12/13.5/15-60-200, VDK-RBD-8/9/10-60-200, VDK-RBD-6/7/8-60-200
Primary DI / UDI-DI
06970057572215, 06970057572352, 06970057572307, 06970057572062, 06970057572109, 06970057572130, 06970057572567, 06941513202861, 06970057572178, 06970057572666, 06970057572499, 06941513203196, 06970057572642, 06970057572604, 06970057572482, 06970057572055, 06941513202083, 06970057572628, 06970057572758, 06970057572475, 06970057572840, 06941513203929, 06970057572765, 06970057572468, 06970057572161, 06941513213195, 06970057572024, 06970057572147, 06970057572512, 06970057572277, 06970057572086, 06970057572369, 06970057572703, 06941513202090, 06970057572093, 06941513203219, 06941513221701, 06941513221909, 06941513221619, 06941513221893, 06941513221879, 06941513221817, 06941513221787, 06941513221848, 06941513221671, 06941513221855, 06941513221749, 06941513221664, 06941513221626
Basic UDI-DI
697005757029HU, 697005757021HC, 697005757032HH, 697005757001H6, 697005757030HD, 697005757027HQ, 697005757028HS, 697005757080HU, 697005757079JB
EMDN Code
G03010199 Gastrointestinal endoscopy, balloon catheters - other
Device Class
Class IIa
EU market of registration
France

Manufacturer details

EUDAMED SRN
CN-MF-000008462
Authorised representative
Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001

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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