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Silicone 3-way Foley Balloon Catheter

by Fortune Medical Instrument Corp. 2 variants

Ref 1830-0526

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

CE MDD

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/MDD EUDAMED NumberB-14710961932588 Basic UDI-DI Date21 Apr 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number14710961932588 UDI-DI Date11 Mar 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.

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  • Withdrawn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/MDD Active
  • United States GUDID listing Listed

Specification

EUDAMED · GUDID

Trade Name
Silicone 3-way Foley Balloon Catheter EUDAMED
Silicone 3-way Foley Balloon Catheter,Female EUDAMED
Silicone 3-way Foley Balloon Catheter (Standard Balloon) GUDID
Generic Name
Indwelling urethral drainage balloon catheter, non-antimicrobial
Model / Reference
1830-0526
Primary DI / UDI-DI
14710961932588, 04710961932581
Basic UDI-DI
B-14710961932588, B-04710961932581
510(k) Number
FDA Product Code
EZL
EMDN Code
U020299 Ureteral catheters with balloon - other
GMDN Term
Indwelling urethral drainage balloon catheter, non-antimicrobial
Device Class
Class IIb EUDAMED
Class II GUDID
Regulation Number
876.5130
EU market of registration
Malta
Netherlands
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device ClassEUDAMED
Class IIb
GUDID
Class II

Manufacturer details

EUDAMED SRN
TW-MF-000009221
Authorised representative
Emergo Europe B.V. NL-AR-000000116

Other devices from Fortune Medical Instrument Corp.

See all devices from Fortune Medical Instrument Corp. →

Properties

  • Sterile
  • Single Use
  • Lot / Batch Number
  • Expiration Date
  • Manufacturing Date

Other properties (17)

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