SOPRO

Registration Details

Registration Name: SOPRO
Registration Number: 9615782
FEI Number: 3004084693
Status: Active
Expiry Year: 2026
Initial Importer: No
Address: ZAC ATHELIA IV, AVENUE DES GENEVRIERS
City: LA CIOTAT CEDEX Bouches-du-Rhone
Country: FR

Regulatory Submissions

510(k) Number: K973798

Owner / Operator

Firm Name: SATELEC-ACTEON GROUP
Operator Number: 9004992
Address: 1001 Briggs Rd, Suite 220
City: Mount Laurel
State: NJ
Postal Code: 08054
Country: US
Correspondent: Noelle Zuccarello

US Agent

Business Name: Acteon, Inc
Contact Name: Noelle Zuccarello
Address: 1001 Briggs Rd
City: Mount Laurel
State: NJ
ZIP: 08054
Country: US
Email: [email protected]
Phone: 800 2896367 ext. 280

Products

Device Name	Product Code	Device Class	Medical Specialty	Exempt	Created
Camera, Television, Endoscopic, Without Audio	FWF	Class 1	General, Plastic Surgery	No	2009-10-29
Endoscopic Video Imaging System/Component, Gastroenterology-Urology	FET	Class 2	Gastroenterology, Urology	No	2007-12-13
Laparoscope, General & Plastic Surgery	GCJ	Class 2	Gastroenterology, Urology	No	2009-04-06
Unit, Operative Dental, Accessories	NRD	Class 1	Dental	No	2025-03-04
Source, Carrier, Fiberoptic Light	EQH	Class 1	Ear, Nose, Throat	No	2013-09-10
Solid State X-Ray Imager (Flat Panel/Digital Imager)	MQB	Class 2	Radiology	No	2009-03-26
Unit, X-Ray, Extraoral With Timer	EHD	Class 2	Dental	No	2009-03-26
System, X-Ray, Extraoral Source, Digital	MUH	Class 2	Dental	No	2009-03-26
Insufflator, Laparoscopic	HIF	Class 2	Obstetrics/Gynecology	No	2016-06-17
Unit, Operative Dental	EIA	Class 1	Dental	No	2007-12-13
Plaque Disclosing Kit	NYH	Class 2	Dental	No	2013-03-13
Laser, Fluorescence Caries Detection	NBL	Class 2	Dental	No	2013-03-13
Led Light Source	NTN	Class 2	Gastroenterology, Urology	No	2011-04-04
Light Source, Fiberoptic, Routine	FCW	Class 2	Gastroenterology, Urology	No	2011-04-04
Tubing/Tubing With Filter, Insufflation, Laparoscopic	NKC	Class 1	Obstetrics/Gynecology	No	2009-11-24
Arthroscope	HRX	Class 2	Orthopedic	No	2008-07-17

Proprietary Names

SOPRO S397 SOPRO 397 3CCD HD SOPRO S-357 VIDEO IMAGING SYSTEM SOPRO 184 Digital Endoscopy Camera SOPRO S098 Symbioz Master SOPRO S198 Symbioz Camera SOPRO S398 Symbioz Camera SOPRO S181 SOPRO 181 UBICAM SOPRO - UBICAM FULL HD - S191 SOPRO S-57 VIDEO IMAGING SYSTEM C50 INTRAORAL CAMERA D C20 INTRAORAL CAMERA SOPRO S52D DIGITAL VIDEO LAPAROSCOP DiGILAP Titanium S165 DUO Sopro PSPIX S698 Symbioz Flow PSPIX2 SOPRO 61D SOPRO 161D SOPRO S57D DIGITAL OPERATING ROOM C SOPIX 2 SOPRO S-52 ELECTRONIC VIDEO LAPAROS Sopro S-52 Digital Viedo Laparoscope SOPRO S555 INTRAORAL DENTAL CAMERA SOPRO 162 CAMERA SOPIX INSIDE, SOPIX2 INSIDE SOPIX PLUG-IN, SOPIX2 PLUG-IN Mini Dock USB2 Mini Dock U USB2 SOPRO S-41 & 41S VIDEO IMAGING SYST Sopro S-41 & S41S Video Imaging System SOPRO 281 LED LIGHT SOURCE UBILED Tubing set Laparoscopic Insufflatio Tubing w/filter laparoscopic insuff SOPRO 225 DUAL HALOGEN LIFG SOURCE SOPRO 225 Dual Halogen Light Source C50 SOPRO 67D OPERATING ROOM CAMERA SOPRO 595 INTRA ORAL CAMERA SOPRO 617 INTRA OTAL CAMERA SOPRO 717 INTRA ORAL CAMERA SOPRO 717 FIRST SOPRO S51D DIGITAL ENDOSCOPY CAMERA S575 INTRAORAL DOCKING DENTAL CAMER S-575 Intraoral Docking Dental Camera SOPRO 670 Arthroscopic Pump SOPRO 640 Insufflator Laparoscopic SOPRO 367D 3CCD FULL DIGITAL ENDOSO SOPIX SOPRO SOPIX SOPRO S298 Symbioz Led SOPRO S284 Led Light Source Laser Flourescence Caries Detection Caries Detection Device SOPROLIFE SOPRO LIGHT SOURCES AND ACCESSORIES

Establishment Types

Manufacture Medical Device Repack or Relabel Medical Device