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Balloon Inflators

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

Ref VDK-IF-12

Active European Union. Also listed in GUDID (US).

CE MDR

Valid until

Not listed

EUDAMED holds no validity date

FDA recalls

Not checked

No FDA submission to match recalls against

Documents

None linked in EUDAMED

A group certificate may exist

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, GUDID, synced 24 Oct 2026. What this means

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number697005757102HD Basic UDI-DI 06970057578422UDI-DIDate16 Apr 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number06970057578422 UDI-DI Date20 Aug 2024ListedStatusListed GUDID: in commercial distribution

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

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDR Active
  • United States GUDID listing Listed

Specification

EUDAMED · GUDID

Generic Name
Catheter/overtube balloon inflator, single-use
Model / Reference
VDK-IF-12
Primary DI / UDI-DI
06970057578422
Basic UDI-DI
697005757102HD
FDA Product Code
PTM
EMDN Code
G03010199 Gastrointestinal endoscopy, balloon catheters - other
GMDN Term
Catheter/overtube balloon inflator, single-use
Device Class
Class I EUDAMED
Class II GUDID
Regulation Number
870.1650
EU market of registration
France
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device ClassEUDAMED
Class I
GUDID
Class II

Manufacturer details

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

Other devices from Jiangsu Vedkang Medical Science and Technology Co., Ltd.

See all devices from Jiangsu Vedkang Medical Science and Technology Co., Ltd. →

Properties

  • Sterile
  • Single Use
  • Measuring Function
  • Prescription Use
  • Premarket Exempt
  • Lot / Batch Number
  • Expiration Date
  • Manufacturing Date

Other properties (16)

  • 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
  • Incorporates Medicinal Product: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Serial Number: No