FDA Registration
Active
🇫🇷 France
PRINCE MEDICAL SAS
Reg #: 3000296634
·
FEI: 3000296634
·
Expires 2026
Products
6
Proprietary Names
10
Establishment Types
2
Classifications
6
Registration Details
- Registration Name
- PRINCE MEDICAL SAS
- Registration Number
- 3000296634
- FEI Number
- 3000296634
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- 64 RUE GUTENBERG
- City
- ERCUIS Oise
- Country
- FR
Regulatory Submissions
- 510(k) Number
- K923464
- PMA Number
- P140008
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 |
| Evacuator, Bladder, Manually Operated | FFD | Class 1 | Gastroenterology, Urology | No | 2023-01-17 |
| Retractor | GAD | Class 1 | General, Plastic Surgery | No | 2015-04-08 |
| Implant, Intragastric For Morbid Obesity | LTI | Class 3 | Unknown | No | 2024-01-03 |
| Device, Cystometric, Hydraulic | FEN | Class 2 | Gastroenterology, Urology | No | 2021-12-13 |
| Cystometric Gas (Carbon-Dioxide) On Hydraulic Device | FAP | Class 2 | Gastroenterology, Urology | No | 2006-09-07 |
Proprietary Names
BALLOON FOR ECHOENDOSCOPY
Extraction kit for gastric balloon
VIPER Extraction Forceps 2 Pincers
Extraction Kit for gastric balloon/ Endoline PUNC Deflation needle for gastric balloon
VS1490740 Catheter for urethrocystometry 3 lumen CH7
VS1611250 Rectal latex balloon catheter Diam12
VS1621032 Rectal silicone balloon catheter diam10
VS1480840 Catheter for cystometry 2 lumen CH8
VS1480640 Catheter for cystometry 2 lumen CH6
URODYNAMIC MEASUREMENT
Establishment Types
Manufacture Medical Device for Another Party (Contract Manufacturer)
Manufacture Medical Device