FDA Registration
Active
🇹🇳 Tunisia
BALLOON FOR ECHOENDOSCOPY
Reg #: 3009346747
·
FEI: 3009346747
·
Expires 2025
Products
1
Proprietary Names
1
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- PRINCE MEDICAL INDUSTRY SUARL
- Registration Number
- 3009346747
- FEI Number
- 3009346747
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- PARC ACTIVITES ECONOMIQUES DE BIZERTE
- City
- BIZERTE
- Country
- TN
Regulatory Submissions
- 510(k) Number
- K180731
Owner / Operator
- Firm Name
- OMERIN CABLES SAS
- Operator Number
- 9091979
- Address
- Zone industrielle 63600 Ambert - France
- City
- AMBERT
- State
- Auvergne-Rhone-Alpes
- Postal Code
- 63600
- Country
- FR
US Agent
- Business Name
- OMERIN
- Contact Name
- Michael Stark
- Address
- 95 RESEARCH PARKWAY, 95 RESEARCH PARKWAY
- City
- Meriden
- State
- CT
- ZIP
- 06450
- Country
- US
- [email protected]
- Phone
- 203 2372297
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Endoscopic Ultrasound System, Gastroenterology-Urology | ODG | Class 2 | Gastroenterology, Urology | No | 2022-12-21 |
Proprietary Names
BALLOON FOR ECHOENDOSCOPY
Establishment Types
Manufacture Medical Device for Another Party (Contract Manufacturer)