FDA Registration
Active
🇳🇱 Netherlands
UroGen Ureteral Catheter
Reg #: 3013530345
·
FEI: 3013530345
·
Expires 2025
Products
1
Proprietary Names
1
Establishment Types
2
Classifications
1
Registration Details
- Registration Name
- MED PRO MEDICAL B.V
- Registration Number
- 3013530345
- FEI Number
- 3013530345
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- Vendelier 45 E
- City
- Veenendaal Utrecht
- Country
- NL
Regulatory Submissions
- 510(k) Number
- K180354
Owner / Operator
- Firm Name
- MED pro Medical B.V
- Operator Number
- 10053600
- Address
- Vendelier 45 E
- City
- Veenendaal
- State
- Utrecht
- Postal Code
- 3905PC
- Country
- NL
- Correspondent
- Andre ten Brinke
US Agent
- Business Name
- Ebner Medical
- Contact Name
- Alex Ebner
- Address
- 2230 Park Ave 202
- City
- Cincinnati
- State
- OH
- ZIP
- 45206
- Country
- US
- [email protected]
- Phone
- 800 4970851
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Catheter, Urological | KOD | Class 2 | Gastroenterology, Urology | No | 2019-06-26 |
Proprietary Names
UroGen Ureteral Catheter
Establishment Types
Manufacture Medical Device for Another Party (Contract Manufacturer)
Export Device to the United States But Perform No Other Operation on Device