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Stone Extraction Balloons

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

Ref VDK-BAL-23-11/13/15-B

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

CE MDR

Valid until

Not listed

EUDAMED holds no validity date

FDA recalls

None found

in data synced 22 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, GUDID, synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number697005757073HX Basic UDI-DI 06970057571027UDI-DIDate22 Apr 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number06970057571027 UDI-DI Date14 Apr 2026ListedStatusListed 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.

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

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  • Withdrawn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

Trade Name
Stone Extraction Balloons EUDAMED
Stone Extraction Balloon GUDID
Generic Name
ERCP catheter, balloon, non-electrical, stone-retrieval
Model / Reference
VDK-BAL-23-11/13/15-B
Primary DI / UDI-DI
06970057571027
Basic UDI-DI
697005757073HX
510(k) Number
FDA Product Code
GCA
EMDN Code
G03050101 Digestive endoscopy, retrieval balloon devices
GMDN Term
ERCP catheter, balloon, non-electrical, stone-retrieval
Device Class
Class IIa EUDAMED
Class II GUDID
Regulation Number
876.5010
EU market of registration
France
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Device ClassEUDAMED
Class IIa
GUDID
Class II
Contains LatexEUDAMED
Yes
GUDID
No

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
  • Contains Latex YesEUDAMEDNoGUDID
  • Prescription Use
  • Lot / Batch Number
  • Expiration Date
  • Manufacturing Date

Other properties (17)

  • Implantable: No
  • Reusable: 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
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No
  • Serial Number: No