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UroMax Ultra™

by Boston Scientific Corporation 32 variants

Ref M0062251360

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 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number01915060000000000000043MJ Basic UDI-DI 08714729302421UDI-DIDate28 Oct 2025RegisteredStatusActive
United StatesGUDID listing GUDID Number08714729302421 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  • Withdrawn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 Active
  • United States GUDID listing Listed

Specification

EUDAMED · GUDID

Trade Name
UroMax Ultra™ EUDAMED
UroMax Ultra Kit GUDID
Generic Name
Urethral dilatation catheter, non-medicated
Device Name
Uromax Ultra with Inflator
Model / Reference
M0062251360
Primary DI / UDI-DI
08714729302421
Basic UDI-DI
01915060000000000000043MJ
FDA Product Code
KOE, EZN
EMDN Code
V0599 Clinical procedures kits not included in other classes - other
GMDN Term
Urethral dilatation catheter, non-medicated
Device Class
Class IIa EUDAMED
Class II GUDID
Regulation Number
876.5520, 876.5470
Medical Purpose
Balloon Dilatation Catheter Kit
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device ClassEUDAMED
Class IIa
GUDID
Class II

Manufacturer details

EUDAMED SRN
US-PR-000008885

Related devices

Category: Ophthalmic surgical procedure kit, non-medicated, single-use

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Properties

  • Sterile
  • Single Use
  • Prescription Use
  • Convenience Kit
  • Lot / Batch Number
  • Expiration Date

Other properties (8)

  • Implantable: No
  • Contains Latex: No
  • Over-the-Counter: No
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No
  • Serial Number: No
  • Manufacturing Date: No