FDA Registration
Active
🇮🇱 Israel
UROGEN PHARMA LTD.
Reg #: 3013024191
·
FEI: 3013024191
·
Expires 2026
Products
5
Proprietary Names
7
Establishment Types
1
Classifications
5
Registration Details
- Registration Name
- UROGEN PHARMA LTD.
- Registration Number
- 3013024191
- FEI Number
- 3013024191
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- 9 Ha'Ta'asiya Street
- City
- Ra'anana Central
- Country
- IL
Regulatory Submissions
- 510(k) Number
- K180345
Owner / Operator
- Firm Name
- Urogen Pharma Ltd.
- Operator Number
- 10055966
- Address
- 400 Alexander Park Drive
- City
- Princeton
- State
- NJ
- Postal Code
- 08540
- Country
- US
- Correspondent
- James Ottinger
US Agent
- Business Name
- Urogen Pharma Inc.
- Contact Name
- James Ottinger
- Address
- 400 Alexander Park Drive, 4th Floor
- City
- Princeton
- State
- NJ
- ZIP
- 08540
- Country
- US
- [email protected]
- Phone
- 610 7451230
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Piston Syringe Lever | QBL | Class 2 | General Hospital | No | 2018-10-31 |
| Catheter, Urological | KOD | Class 2 | Gastroenterology, Urology | No | 2018-10-31 |
| Catheter Care Tray | OHR | Class 2 | Gastroenterology, Urology | No | 2020-05-12 |
| Equipment, Laboratory, General Purpose, Labeled Or Promoted For A Specific Medical Use | LXG | Class 1 | Clinical Chemistry | No | 2017-10-24 |
| Catheter, Coude | EZC | Class 2 | Gastroenterology, Urology | No | 2022-05-17 |
Proprietary Names
Uroject12 Syringe Lever
UroGen Ureteral Catheter
Ureteral Catheter Administration Kit
Intravesical Administation Kit
Chilling Block Urogen
Universal Chilling Block
UroGen Urinary Catheter
Establishment Types
Develop Specifications But Do Not Manufacture At This Facility