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Hercules 3 Stage Balloon Esophageal

by Wilson-Cook Medical, Inc. 5 variants

Ref HBD-10-11-12

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

CE MDR CE MDD

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 25 Oct 2026. What this means

Regulatory status

as of registry sync 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED NumberB-00827002319257 Basic UDI-DI 00827002319257UDI-DIDate6 May 2026RegisteredStatusActive
European UnionCE/MDD EUDAMED NumberB-00827002319257 Basic UDI-DI 00827002319257UDI-DIDate6 May 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number00827002319257 UDI-DI Date24 Sep 2016ListedStatusListed 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  • Withdrawn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, CE/MDD Active
  • United States GUDID listing Listed

Specification

EUDAMED · GUDID

Trade Name
Hercules® EUDAMED
Hercules GUDID
Generic Name
Gastrointestinal/biliary dilation balloon catheter, non-medicated
Device Name
Sterile GI Balloon Dilators
Model / Ref / Catalog
HBD-10-11-12, G31925
Primary DI / UDI-DI
00827002319257
Basic UDI-DI
B-00827002319257, 0827002WCM00000000040ML
FDA Product Code
KNQ
EMDN Code
G03010199 Gastrointestinal endoscopy, balloon catheters - other
GMDN Term
Gastrointestinal/biliary dilation balloon catheter, non-medicated
Device Class
Class I EUDAMED
Class II GUDID
Regulation Number
876.5365
EU market of registration
Germany
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Model / ReferenceEUDAMED
HBD-10-11-12
GUDID
G31925
Device ClassEUDAMED
Class I
GUDID
Class II

Manufacturer details

EUDAMED SRN
US-MF-000002658
Authorised representative
COOK MEDICAL EUROPE LIMITED IE-AR-000000907

Other devices from Wilson-Cook Medical, Inc.

See all devices from Wilson-Cook Medical, Inc. →

Properties

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

Other properties (17)

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