Identity
- Trade Name
- UroMax Ultra™ EUDAMEDUroMax Ultra Kit FDA UDI
- Generic Name
- Urethral dilatation catheter, non-medicated FDA UDI
- Device Name
- Uromax Ultra with Inflator EUDAMEDBalloon Dilatation Catheter Kit FDA UDI
- Model / Reference
- M0062251300 EUDAMEDFDA UDI
- Description
- Balloon Dilatation Catheter Kit FDA UDI
Identifiers
- Primary DI / UDI-DI
- 08714729341376 EUDAMEDFDA UDI
- Basic UDI-DI
- 01915060000000000000043MJ EUDAMED
- FDA Product Code
- KOE FDA UDIEZN 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 EUDAMEDClass II FDA UDI
- Regulation Number
- 876.5520 FDA UDI876.5470 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
Category: Ophthalmic surgical procedure kit, non-medicated, single-use
UroMax Ultra™ by Boston Scientific Corporation — Class IIa — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
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Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 01915060000000000000043MJ | Class IIa | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | Pending data |
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Manufacturer
- Manufacturer
- Boston Scientific Corporation
- EUDAMED SRN
- US-PR-000008885
Sources (2)
- EUDAMED 609f903e-3946-4392-8577-3c2a0ff7a596 61 fields · synced Jun 18, 2026
- FDA UDI 130a4bb8-af61-4efb-9f79-874fffc1f1c5 34 fields · synced May 24, 2026