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UroMax Ultra™

EUDAMEDFDA UDI

Class IIa (EU MDR)

Ref M0062251270

by Boston Scientific Corporation

Identity

Trade Name
UroMax Ultra™ EUDAMED
UroMax Ultra Kit FDA UDI
Generic Name
Urethral dilatation catheter, non-medicated FDA UDI
Device Name
Uromax Ultra with Inflator EUDAMED
Balloon Dilatation Catheter Kit FDA UDI
Model / Reference
M0062251270 EUDAMEDFDA UDI
Description
Balloon Dilatation Catheter Kit FDA UDI

Identifiers

Primary DI / UDI-DI
08714729341345 EUDAMEDFDA UDI
Basic UDI-DI
01915060000000000000043MJ EUDAMED
FDA Product Code
KOE FDA UDI
EZN FDA UDI
EMDN Code
V0599 CLINICAL PROCEDURES KITS NOT INCLUDED IN OTHER CLASSES - OTHER EUDAMED
GMDN Term
Urethral dilatation catheter, non-medicated FDA UDI

Classification

Device Class
Class IIa EUDAMED
Class II FDA UDI
Regulation Number
876.5520 FDA UDI
876.5470 FDA UDI
Medical Purpose
Balloon Dilatation Catheter Kit EUDAMED
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

EUDAMEDFDA UDI

Single Use

Yes

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

Yes

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

No

FDA UDI

UroMax Ultra™ by Boston Scientific Corporation — Class IIa — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS

Authorization Coverage (2 countries)

Regulatory Authorizations

European Union Active

CE/MDR

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Boston Scientific Corporation
EUDAMED SRN
US-PR-000008885

Sources (2)

  • EUDAMED cb2cb5a9-b5bf-4f64-a942-ffcc9a594b87 61 fields · synced Jun 18, 2026
  • FDA UDI 906af759-9b74-4153-b0fd-0e5bda933dcf 34 fields · synced May 30, 2026