Data / Medical devices / France / Prince Medical SAS
Prince Medical SAS: FDA-registered device maker in ERCUIS Oise, France, 2 510(k) clearances and 1 PMA approval
Prince Medical SAS is registered with the FDA (registration 3000296634) in ERCUIS Oise, France. It lists 6 device types. The FDA files 2 510(k) clearances and 1 PMA approval under its listings, the newest dated August 5, 2015. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3000296634
- Address
- 64 Rue Gutenberg, ERCUIS Oise, France, 60530
- Owner or operator
- OMERIN CABLES SAS (9091979)
- Roles
- Contract manufacturer, Manufacturer
- First device listed
- September 7, 2006
- Registered through
- 2026
- Brand names listed
- BALLOON FOR ECHOENDOSCOPY, Extraction Kit for gastric balloon/ Endoline PUNC Deflation needle for gastric balloon, Extraction kit for gastric balloon, URODYNAMIC MEASUREMENT, VIPER Extraction Forceps 2 Pincers, VS1480640 Catheter for cystometry 2 lumen CH6, VS1480840 Catheter for cystometry 2 lumen CH8, VS1490740 Catheter for urethrocystometry 3 lumen CH7 and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Cystometric Gas (Carbon-Dioxide) On Hydraulic Device | FAP | 2 | Manufacturer | accessdata.fda.gov |
| Device, Cystometric, Hydraulic | FEN | 2 | Manufacturer | accessdata.fda.gov |
| Endoscopic Ultrasound System, Gastroenterology-Urology | ODG | 2 | Contract manufacturer | accessdata.fda.gov |
| Evacuator, Bladder, Manually Operated | FFD | 1 | Manufacturer | accessdata.fda.gov |
| Implant, Intragastric For Morbid Obesity | LTI | 3 | Manufacturer | accessdata.fda.gov |
| Retractor | GAD | 1 | Manufacturer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| February 5, 1993 | K923464 | URODYNAMIC CATHETERS | FAP | Substantially Equivalent | R.L. Medical Corp. | accessdata.fda.gov |
| September 4, 1992 | K920777 | LABORIE URODYNAMICS PROCESSOR | FAP | Substantially Equivalent | R. Laborie Surgical , Ltd. | accessdata.fda.gov |
PMA approvals
Premarket approvals this establishment lists, with the supplements the FDA has decided since.
| Approved | PMA number | Device | Product code | Supplements | Latest decision | Source |
|---|---|---|---|---|---|---|
| August 5, 2015 | P140008 | ORBERA INTRAGASTRIC BALLOON | LTI | 23 | January 5, 2026 | accessdata.fda.gov |
Compare with other makers
- All makers of Cystometric Gas (Carbon-Dioxide) On Hydraulic Device
- All makers of Retractor
- All makers of Endoscopic Ultrasound System, Gastroenterology-Urology
- All makers of Device, Cystometric, Hydraulic
- All makers of Implant, Intragastric For Morbid Obesity
- All makers of Evacuator, Bladder, Manually Operated
Updated January 5, 2026. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.