PRINCE MEDICAL SAS

FDA Device Registration & Listing · ERCUIS Oise, FR · Registration 3000296634

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
3000296634
FEI Number
3000296634
Entity Name
PRINCE MEDICAL SAS
City/State/Country
ERCUIS Oise, FR
Establishment Address
64 RUE GUTENBERG, ERCUIS Oise 60530, FR
Establishment Type(s)
Manufacture Medical Device
Owner / Operator
OMERIN CABLES SAS (Owner Number: 9091979)
Owner / Operator Contact Address
Zone industrielle 63600 Ambert - France, AMBERT, FR-ARA 63600, FR
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
K923464
PMA Number
N/A

All Registered 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

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
ODG Endoscopic Ultrasound System, Gastroenterology-Urology Gastroenterology, Urology Class 2 876.1500 2022-12-21
FFD Evacuator, Bladder, Manually Operated Gastroenterology, Urology Class 1 876.4370 2023-01-17
GAD Retractor General, Plastic Surgery Class 1 878.4800 2015-04-08
LTI Implant, Intragastric For Morbid Obesity Unknown Class 3 N/A 2024-01-03
FEN Device, Cystometric, Hydraulic Gastroenterology, Urology Class 2 876.1620 2021-12-13
FAP Cystometric Gas (Carbon-Dioxide) On Hydraulic Device Gastroenterology, Urology Class 2 876.1620 2006-09-07

Official Correspondent

No official correspondent registered.

US Agent Details

Michael Stark Business: OMERIN Email: michael.stark@omerin.com Phone: (203) 2372297

Related Public Records

Same Entity

OMERIN CABLES SAS
View consolidated registration, premarket clearance, and recall records for this applicant.
View Entity Profile →

Related 510(k) Records

510(k) Number Applicant Device Name Decision Date
K922626 Andronic Devices, Ltd. ADEPT INSTRUMENT POSITIONING ACCESSORY 1992-10-19
K820290 The Anspach Effort, Inc. SELF RETAINING RETRACTOR FOR HAND SURG 1982-03-05
K760422 Cutter Laboratories, Inc. SURGICAL RETRACTOR 1976-08-23

Related Recall Records

Recall ID Recalling Firm Recall Class Product Description
Z-0031-2014 Aesculap, Inc. 1
UNITRAC Pneumatic Retraction Arm. A support arm used to hold surgical instruments during surgical procedures.

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3000296634. Last updated year: 2026. Please use registration number 3000296634 when referencing this establishment in official correspondence.
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