Cogentix Medical Inc

FDA Filings

This page includes the latest FDA filings for Cogentix Medical Inc. Currently, you will find the latest 100 filings for Premarket Notifications, Premarket Applications, De Novo Applications, and GUDID registrations.

USA

BOERSE STUTTGART

7XC

DUNS 780024725

FDA Registration(s)

• Registration Number: 2242464
• FEI Number: 2242464
• Name: COGENTIX MEDICAL, INC.
• Owner & Operator: COGENTIX MEDICAL, INC.
• Contact Address: 40 RAMLAND RD. SOUTH --; Orangeburg NY 10962 US
• Official Correspondent:
  • Christa - Blaisdell
  • x-952-4266161-x
• Registration Status: 1
• Initial Importer: N
• Registration Expiration: 2020-04-25
• Registration Address: 40 Ramland Rd S ; ORANGEBURG, NY 10962 US
• Establishment Type:
  • Develop Specifications But Do Not Manufacture At This Facility
  • Manufacture Medical Device
  • Repack or Relabel Medical Device
  • Manufacture Medical Device for Another Party (Contract Manufacturer)

• Registration Number: 1223490
• FEI Number: 1000136543
• Name: COGENTIX MEDICAL, INC.
• Owner & Operator: COGENTIX MEDICAL, INC.
• Contact Address: 135 Flanders Road --; Westborough MA 01581 US
• Official Correspondent:
  • Christa - Blaisdell
  • x-952-4266161-x
• Registration Status: 1
• Initial Importer: N
• Registration Expiration: 2020-04-25
• Registration Address: 135 Flanders Rd ; Westborough, MA 01581 US
• Establishment Type:
  • Manufacture Medical Device
  • Manufacture Medical Device for Another Party (Contract Manufacturer)

FDA Filings

Device Company	Device	Date
GUDID 20874485002750 COGENTIX MEDICAL, INC.	Nasal Cytology Brush	2019-07-02
GUDID 20874485002712 COGENTIX MEDICAL, INC.	Endoscopic Cytology Brush	2019-07-02
GUDID 00874485003173 COGENTIX MEDICAL, INC.	EndoSheath Technology 08-5102	2019-07-02
GUDID 00874485003166 COGENTIX MEDICAL, INC.	EndoSheath Technology 08-5101	2019-07-02
GUDID 00874485002954 COGENTIX MEDICAL, INC.	Flexible Fiber Laryngoscope, Standard Set Reconditioned 02-4202P	2019-07-02
GUDID 00874485002947 COGENTIX MEDICAL, INC.	Flexible Fiber Laryngoscope, Standard Set Reconditioned 02-4502P	2019-07-02
GUDID 00874485002879 COGENTIX MEDICAL, INC.	Flexible Video Esophagoscope (NTSC) Reconditioned 03-5201P	2019-07-02
GUDID 00874485002848 COGENTIX MEDICAL, INC.	Flexible Video Bronchoscope (NTSC) Reconditioned 04-5203P	2019-07-02
GUDID 00874485002787 COGENTIX MEDICAL, INC.	Flexible Video Laryngoscope (NTSC) Reconditioned 02-7201P	2019-07-02
GUDID 00874485002763 COGENTIX MEDICAL, INC.	Flexible Video Laryngoscope (NTSC) Reconditioned 02-5201P	2019-07-02
GUDID 00874485002749 COGENTIX MEDICAL, INC.	Endoscopic Injection Needle	2019-07-02
GUDID 00874485002671 COGENTIX MEDICAL, INC.	Flexible Video Laryngoscope (NTSC) 02-7201	2019-07-02
GUDID 00874485002565 COGENTIX MEDICAL, INC.	Video Processor 07-5051P	2019-07-02
GUDID 00874485002367 COGENTIX MEDICAL, INC.	Flexible Video Bronchoscope (NTSC) 04-5203	2019-07-02
GUDID 00874485001629 COGENTIX MEDICAL, INC.	Flexible Fiber Laryngoscope, Standard Set 02-4502	2019-07-02
GUDID 00874485001544 COGENTIX MEDICAL, INC.	Flexible Fiber Bronchoscope 04-4201	2019-07-02
GUDID 00874485001360 COGENTIX MEDICAL, INC.	Flexible Fiber Laryngoscope, Standard Set 02-4202	2019-07-02
GUDID 00874485000943 COGENTIX MEDICAL, INC.	Video Processor 07-5051	2019-07-02
GUDID 00874485000868 COGENTIX MEDICAL, INC.	Flexible Video Laryngoscope (NTSC) 02-5201	2019-07-02
GUDID 00874485000844 COGENTIX MEDICAL, INC.	Flexible Video Esophagoscope (NTSC) 03-5201	2019-07-02
GUDID 20874485003016 COGENTIX MEDICAL, INC.	EndoSheath Technology 03-5102	2019-02-21
GUDID 20874485002996 COGENTIX MEDICAL, INC.	EndoSheath Technology 03-5101	2019-02-21
GUDID 00874485003227 COGENTIX MEDICAL, INC.	UNITY 9000	2019-02-21
GUDID 00874485003210 COGENTIX MEDICAL, INC.	UNITY 9100	2019-02-21
GUDID 00874485003159 COGENTIX MEDICAL, INC.	EndoSheath Technology 08-4102	2019-02-21
GUDID 00874485003142 COGENTIX MEDICAL, INC.	EndoSheath Technology 08-4101	2019-02-21
GUDID 00874485003135 COGENTIX MEDICAL, INC.	EndoSheath Technology 04-5115	2019-02-21
GUDID 00874485003128 COGENTIX MEDICAL, INC.	EndoSheath Technology 04-5113	2019-02-21
GUDID 00874485003111 COGENTIX MEDICAL, INC.	EndoSheath Technology 04-5112	2019-02-21
GUDID 00874485003104 COGENTIX MEDICAL, INC.	EndoSheath Technology 04-5111	2019-02-21
GUDID 00874485003098 COGENTIX MEDICAL, INC.	EndoSheath Technology 04-5105	2019-02-21
GUDID 00874485003074 COGENTIX MEDICAL, INC.	EndoSheath Technology 04-5102	2019-02-21
GUDID 00874485003067 COGENTIX MEDICAL, INC.	EndoSheath Technology 04-5101	2019-02-21
GUDID 00874485003050 COGENTIX MEDICAL, INC.	EndoSheath Technology 04-4105	2019-02-21
GUDID 00874485003043 COGENTIX MEDICAL, INC.	EndoSheath Technology 04-4103	2019-02-21
GUDID 00874485003036 COGENTIX MEDICAL, INC.	EndoSheath Technology 04-4102	2019-02-21
GUDID 00874485003029 COGENTIX MEDICAL, INC.	EndoSheath Technology 04-4101	2019-02-21
GUDID 00874485002572 COGENTIX MEDICAL, INC.	Video Processor 07-7001P	2019-02-21
GUDID 00874485002275 COGENTIX MEDICAL, INC.	Video Processor 07-7001	2019-02-21
GUDID 00874485000318 COGENTIX MEDICAL, INC.	Portable LED Light Source 07-3050	2019-02-21
PMN K181292 | OCS COGENTIX MEDICAL, INC.	UNITY Video Processors	2018-12-10
PMN K181292 | FAJ COGENTIX MEDICAL, INC.	UNITY Video Processors	2018-12-10
PMN K181292 | EOX COGENTIX MEDICAL, INC.	UNITY Video Processors	2018-12-10
PMN K181292 | EOQ COGENTIX MEDICAL, INC.	UNITY Video Processors	2018-12-10
PMN K181292 | EOB COGENTIX MEDICAL, INC.	UNITY Video Processors	2018-12-10
FEN COGENTIX MEDICAL, INC.	Catheter for Use with Urodynamics System	2018-12-10
PMN K181292 Cogentix Medical, Inc.	PrimeSight™ UNITY 9000 Video Processor, PrimeSight™ UNITY 9100 Video Processor	2018-11-15
GUDID 00874485002978 COGENTIX MEDICAL, INC.	Flexible Video Cystoscope (NTSC) Intuitive 08-5206	2018-07-06
GUDID 00874485002961 COGENTIX MEDICAL, INC.	Flexible Video Cystoscope (NTSC) 08-5205	2018-07-06
GUDID 00874485002955 COGENTIX MEDICAL, INC.	Flexible Fiber Laryngoscope, Standard Set Recondit 02-4202P	2018-07-06
GUDID 00874485002824 COGENTIX MEDICAL, INC.	Flexible Video Cystoscope (NTSC) Intuitive Reconditioned 08-5203P	2018-07-06
GUDID 00874485002800 COGENTIX MEDICAL, INC.	Flexible Video Cystoscope (NTSC) Reconditioned 08-5201P	2018-07-06
GUDID 00874485001278 COGENTIX MEDICAL, INC.	Flexible Video Cystoscope (NTSC) Intuitive 08-5203	2018-07-06
GUDID 00874485000882 COGENTIX MEDICAL, INC.	Flexible Video Cystoscope (NTSC) 08-5201	2018-07-06
GUDID 00874485001605 COGENTIX MEDICAL, INC.	Flexible Fiberoptic Cystoscope - Intuitive 08-4202	2018-03-29
GUDID 00874485001599 COGENTIX MEDICAL, INC.	Flexible Fiberoptic Cystoscope 08-4201	2018-03-29
PMN K071127 | HIH COGENTIX MEDICAL, INC.	ENT EndoSheath Technology	2014-11-10
PMN K121112 | FGB COGENTIX MEDICAL, INC.	Stryker Video Ureteroscope	2012-11-19
PMN K091768 | EOQ COGENTIX MEDICAL, INC.	BRS-5000 Video Bronchoscope	2011-01-24
PMN K072180 | FFS COGENTIX MEDICAL, INC.	EndoSheath Technology	2009-03-12
PMN K072180 | FFS COGENTIX MEDICAL, INC.	CST-5000 Videocystoscope	2009-03-12
PMN K072180 | FED COGENTIX MEDICAL, INC.	EndoSheath Technology	2009-03-12
PMN K072180 | FED COGENTIX MEDICAL, INC.	CST-5000 Videocystoscope	2009-03-12
PMN K072180 | FAJ COGENTIX MEDICAL, INC.	EndoSheath Technology	2009-03-12
PMN K072180 | FAJ COGENTIX MEDICAL, INC.	CST-5000 Videocystoscope	2009-03-12
PMN K072088 | EOX COGENTIX MEDICAL, INC.	TNE-5000 Videoesaphagoscope	2009-03-12
PMN K072088 | EOX COGENTIX MEDICAL, INC.	EndoSheath Technology	2009-03-12
EQL COGENTIX MEDICAL, INC.	STR-5000 Stroboscopy Unit	2008-07-17
PMN K072180 | FFS COGENTIX MEDICAL, INC.	Digital Cystoscope and EndoSheath	2008-01-14
PMN K072180 | FFS COGENTIX MEDICAL, INC.	CST-5000 Videocystoscope	2008-01-14
PMN K072180 | FED COGENTIX MEDICAL, INC.	Digital Cystoscope and EndoSheath	2008-01-14
PMN K072180 | FED COGENTIX MEDICAL, INC.	CST-5000 Videocystoscope	2008-01-14
PMN K072180 | FAJ COGENTIX MEDICAL, INC.	Digital Cystoscope and EndoSheath	2008-01-14
PMN K072180 | FAJ COGENTIX MEDICAL, INC.	CST-5000 Videocystoscope	2008-01-14
PMN K021344 | EOQ COGENTIX MEDICAL, INC.	Bronschoscope Endosheath System	2007-12-28
PMN K071127 | HIH COGENTIX MEDICAL, INC.	Fiber Cystoscope, EndoSheath & Battery Light Source	2007-12-03
PMN K071127 | HIH COGENTIX MEDICAL, INC.	CST-2000A Cystoscope/Hysteroscope	2007-12-03
FWL COGENTIX MEDICAL, INC.	DVC-2010 DIGITAL VIDEO CAMERA	2007-08-10

Related Finance Registrations

NCAGE Code	1LBV9	COGENTIX MEDICAL, INC.!DBA COGENTIX MEDICAL
CAGE Code	1LBV9	COGENTIX MEDICAL, INC. COGENTIX MEDICAL
S.A.M. Registration	1LBV9 [780024725]	COGENTIX MEDICAL, INC. COGENTIX MEDICAL
DUNS	780024725	Cogentix Medical, Inc.
SEC	0000894237	COGENTIX MEDICAL INC /DE/ of DELAWARE
SEC	894237	COGENTIX MEDICAL INC /DE/ of DELAWARE

U.S. Import Records [external site]

Import ID	Shipment	Cargo Description	Quantity
2018092563371	FOS Sur Mer,France -> New York/Newark Area, Newark, New Jersey	COMPONENTS MEDICAL	3 PKG