COGENT

FDA Registration(s)#

Registration, FEI, Name table
Registration	FEI	Name	Status	Initial importer	Expiration year	Address
1223490	1000136543	COGENTIX MEDICAL, INC.	1	N	2026-01-01	135 Flanders Rd Westborough MA US 01581
2242464	2242464	COGENTIX MEDICAL, INC.	1	N	2026-01-01	40 Ramland Rd S ORANGEBURG NY US 10962
3002806730	3002806730	COGENT TECHNOLOGY LIMITED	1	N	2026-01-01	Landguard Point Enterprise Centre Langer Road Felixstowe Suffolk GB IP11 2BF
3011053604	3011053604	COGENT SPINE LLC	1	N	2020-04-25	7790 Doug Hill San Diego CA US 92127

GUDID Contact Samples#

Sampled from matched GUDID device records for this company; this is not an exhaustive company contact directory.

Source GUDID, Product, Phone table
Source GUDID	Product	Phone	Email
00874485000318	Portable LED Light Source - BLS-1000	866-258-2182	customercare@cogentixmedical.com
00874485000844	Flexible Video Esophagoscope (NTSC) - TNE-5000	866-258-2182	customercare@cogentixmedical.com
00874485002367	Flexible Video Bronchoscope (NTSC) - BRS-5100	866-258-2182	customercare@cogentixmedical.com
00874485002848	Flexible Video Bronchoscope (NTSC) Reconditioned - Reconditioned	866-258-2182	customercare@cogentixmedical.com
00874485002879	Flexible Video Esophagoscope (NTSC) Reconditioned - Reconditioned	866-258-2182	customercare@cogentixmedical.com
00874485003173	EndoSheath Technology - EndoSheath Technology for the CST-5000 Cystoscope	866-258-2182	customercare@cogentixmedical.com
00874485003180	Endoscopic Cytology Brush - 07-9001	866-258-2182	customercare@cogentixmedical.com
00874485003197	Nasal Cytology Brush - 07-9006	866-258-2182	customercare@cogentixmedical.com

cogentixmedical.com

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration key	Listing key	Premarket submission	Device	Product code	Decision date
24921	1675022732	K971813	EMBLA	OLV	1998-01-16
68704	1446631065	K181292	PrimeSight™ UNITY 9000 Video Processor, PrimeSight™ UNITY 9100 Video Processor	EOX	2018-11-15
24921	1644692803	K143198	Synapse Transcutaneous Electrical Stimulation Device	GZJ	2015-05-27
173596	1506326014	K132738	COGENT MED-LIF	MAX	2014-04-15
24921	1928211070	K122516	EMBLETTA MPR	MNR	2013-02-21
24921	1218093011	K111742	MDRIVE	MNR	2011-08-31
24921	1756324378	K092003	CPC SLEEP DATA RECORDER, MODEL M1, AND APPLICATION SOFTWARE	MNR	2009-09-30
46510	1208800338	K091768	VIDEO SCIENCES BRS-5000 VIDEO BRONCHOSCOPE WITH ENDOSHEATH SYSTEM, DPU-5000/DPU-5050 VIDEO PROCESSOR & ACCESSORIES	EOQ	2009-08-03
24921	1811648451	K090730	AKITA JET	CAF	2009-11-13
24921	1492629769	K073682	EMBLETTA GOLD	MNR	2008-08-08
68704	1193496492	K072180	VISION-SCIENCES CST-5000 VIDEO CYSTOSCOPE WITH ENDOSHEATH SYSTEM	FAJ	2007-12-18
46510	1672424177	K072180	VISION-SCIENCES CST-5000 VIDEO CYSTOSCOPE WITH ENDOSHEATH SYSTEM	FAJ	2007-12-18
46510	1774192951	K072088	FLEXIBLE TRANS-NASAL VIDEO ESOPHAGOSCOPE WITH DIGITAL VIDEO PROCESSOR AND DISPOSABLE ENDOSHEATH SYSTEMS	EOX	2007-08-29
46510	1614805623	K071127	FLEXIBLE HYSTEROSCOPE WITH ENDOSHEATH SYSTEM	HIH	2007-11-16
68704	1739901231	K071127	FLEXIBLE HYSTEROSCOPE WITH ENDOSHEATH SYSTEM	HIH	2007-11-16
24921	1831517442	K043132	UNIVERSAL XACTTRACE	MNR	2004-12-21
24921	1243365516	K041904	COMPASS F10 SYSTEM	MNR	2004-09-07
24921	1976446439	K024322	EMBLA N7000	MNR	2003-10-27
46510	1776853273	K021344	B-F200 BRONCHOSCOPE WITH BSS-F21 ENDOSHEATH SYSTEM	EOQ	2002-05-24
24921	1431958197
46510	1066322782
24921	1218093011
68704	1228408619
24921	1264720755
24921	1288612660
24921	1492629769
68704	1632955395
24921	1644692803
24921	1675022732
24921	1811648451
24921	1831517442
68704	1907553034
24921	1928211070
24921	1976446439
68704	2072780751

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product code	Registration listing records	Latest decision
MNR	7	2013-02-21
EOX	2	2018-11-15
EOQ	2	2009-08-03
FAJ	2	2007-12-18
HIH	2	2007-11-16
GZJ	1	2015-05-27
MAX	1	2014-04-15
CAF	1	2009-11-13
OLV	1	1998-01-16

PMN#

PrimeSight™ UNITY 9000 Video Processor, PrimeSight™ UNITY 9100 Video Processor
2018-11-15
Cogentix Medical, Inc.
Cogent Lateral Interbody System
2016-02-25
COGENT SPINE LLC
COGENT MED-LIF XL
2014-10-15
COGENT SPINE LLC
COGENT MED-LIF
2014-04-15
COGENT SPINE LLC
NASAL/EPISTAXIS PACK
2012-04-25
COGENT THERAPEUTICS, LLC
AUTOSTAT II ENA-4 PROFILE ELISA
2000-10-13
COGENT DIAGNOTICS LTD.
AUTOSTAT II ENA-6 PROFILE ELISA
2000-10-13
COGENT DIAGNOTICS LTD.
AUTOSTAT II ANTI-MYELOPEROXIDASE (MPO) ELISA
2000-09-28
COGENT DIAGNOTICS LTD.
MICRO LINK ENDOSCOPIC FIBER CABLE, MODEL B1-90159
2000-07-17
COGENT LIGHT TECHNOLOGIES, INC.
AUTOSTAT II RHEUMATOID FACTOR IGA ELISA
2000-03-03
COGENT DIAGNOTICS LTD.
AUTOSTAT II RHEUMATOID FACTOR IGM ELISA
2000-02-03
COGENT DIAGNOTICS LTD.
AUTOSTAT II ANTI-CARDIOLIPIN SCREEN ELISA
2000-02-01
COGENT DIAGNOTICS LTD.
AUTOSTAT II RHEUMATOID FACTOR IGG ELISA
1999-12-06
COGENT DIAGNOTICS LTD.
AUTOSTAT II ANTI-CARDIOLIPIN IGM ELISA
1999-11-24
COGENT DIAGNOTICS LTD.
AUTOSTAT II ANTI-GLIADIN IGG ELISA
1999-11-12
COGENT DIAGNOTICS LTD.
AUTOSTAT II ANTI-GLIADIN IGA ELISA
1999-11-12
COGENT DIAGNOTICS LTD.
AUTOSTAT II ANTI-CARDIOLIPIN IGG ELISA
1999-09-21
COGENT DIAGNOTICS LTD.
AUTOSTAT II ANTI-GPC ELISA, HY.TEC ANTI-GPC ELISA
1999-08-24
COGENT DIAGNOTICS LTD.
AUTOSTAT II ANTI-GBM ELISA, HY.TEC ANTI-GMB ELISA
1999-08-09
COGENT DIAGNOTICS LTD.
AUTOSTAT II ANTI-SS-B/LA ELISA
1999-04-28
COGENT DIAGNOTICS LTD.
AUTOSTAT II ANTI-SS-A/RO ELISA
1999-04-28
COGENT DIAGNOTICS LTD.
AUTOSTAT II ANTI-JO-1 ELISA
1999-04-28
COGENT DIAGNOTICS LTD.
AUTOSTAT II ANTI-SM/RNP ELISA
1999-04-28
COGENT DIAGNOTICS LTD.
AUTOSTAT II ANTI-PR 3 (C-ANCA)ELISA, HY*TEC ANTI-PR 3 (C-ANCA)ELISA
1999-04-28
COGENT DIAGNOTICS LTD.
AUTOSTAT II ANTI-SCL-70 ELISA
1999-04-28
COGENT DIAGNOTICS LTD.
AUTOSTAT II ANTI-SM ELISA
1999-04-28
COGENT DIAGNOTICS LTD.
AUTOSTAT II ANA SCREEN ELISA
1999-01-28
COGENT DIAGNOTICS LTD.
PARIETEX
1999-01-20
COGENT
AUTOSTAT II ENA SCREEN ELISA
1998-12-28
COGENT DIAGNOTICS LTD.
SOLARTEC SOURCE 270, MODEL # 90123
1998-12-23
COGENT LIGHT TECHNOLOGIES, INC.
COGENLIGHT TECHNOLOGIES XLS ILLUMINATOR SYSTEM
1997-03-28
COGENT LIGHT TECHNOLOGIES, INC.
AUTOSTATTMII ANTI-DSDNA
1997-03-04
COGENT DIAGNOTICS LTD.
AUTOSTAT II ANTI-TPO
1995-04-17
COGENT DIAGNOTICS LTD.
AUTOSTAT II ANTI-THYROGLOBULIN
1994-12-22
COGENT DIAGNOTICS LTD.
LIGHTWEAR(TM) SYST (LIGHTWEAR HEADLIGHT CLIP/HEADBAND)
1994-03-10
COGENT LIGHT TECHNOLOGIES, INC.
COGENT LIGHT ILLUMINATOR 10010 XENON LIGHT SOURCE
1994-02-18
COGENT LIGHT TECHNOLOGIES, INC.
AUTOSTAT ANTI-DSDNA
1993-03-22
COGENT DIAGNOTICS LTD.
AUTOSTAT ANTI-THYROID MICROSOMAL KIT
1993-01-21
COGENT DIAGNOTICS LTD.
AUTOSTAT ANTITHYROGLOBIN
1993-01-21
COGENT DIAGNOTICS LTD.
AUTOSTAT ANTI-THYROGLOBULIN
1992-09-22
COGENT DIAGNOTICS LTD.

42 records. Showing 1-40. Next

GUDID#

Nasal Cytology Brush - 07-9006
COGENTIX MEDICAL, INC.
2016-09-23
Endoscopic Cytology Brush - 07-9001
COGENTIX MEDICAL, INC.
2016-09-23
Flexible Video Esophagoscope (NTSC) Reconditioned - Reconditioned
COGENTIX MEDICAL, INC.
2016-09-22
Flexible Video Bronchoscope (NTSC) Reconditioned - Reconditioned
COGENTIX MEDICAL, INC.
2016-09-22
Flexible Video Bronchoscope (NTSC) - BRS-5100
COGENTIX MEDICAL, INC.
2016-09-22
Flexible Video Esophagoscope (NTSC) - TNE-5000
COGENTIX MEDICAL, INC.
2016-09-22
Portable LED Light Source - BLS-1000
COGENTIX MEDICAL, INC.
2016-09-23
EndoSheath Technology - EndoSheath Technology for the CST-5000 Cystoscope
COGENTIX MEDICAL, INC.
2016-09-23
EndoSheath Technology - EndoSheath Technology for CST-5000 Cystoscope
COGENTIX MEDICAL, INC.
2016-09-23
EndoSheath Technology - EndoSheath Technology for CST-4000 Cystoscope
COGENTIX MEDICAL, INC.
2016-09-23
EndoSheath Technology - EndoSheath Technology for CST-4000 Cystoscope
COGENTIX MEDICAL, INC.
2016-09-23
EndoSheath Technology - EndoSheath Technology for BRS-5100 Video Bronchoscope
COGENTIX MEDICAL, INC.
2016-09-23
EndoSheath Technology - EndoSheath Technology for BRS-5100 Video Bronchoscope
COGENTIX MEDICAL, INC.
2016-09-23
EndoSheath Technology - EndoSheath Technology for BRS-5100 Video Bronchoscope
COGENTIX MEDICAL, INC.
2016-09-23
EndoSheath Technology - EndoSheath Technology for BRS-5100 Video Bronchoscope
COGENTIX MEDICAL, INC.
2016-09-23
EndoSheath Technology - EndoSheath Technology for BRS-5000 Video Bronchoscope
COGENTIX MEDICAL, INC.
2016-09-23
EndoSheath Technology - EndoSheath Technology for BRS-5000 Video Bronchoscope
COGENTIX MEDICAL, INC.
2016-09-23
EndoSheath Technology - EndoSheath Technology for BRS-5000 Video Bronchoscope
COGENTIX MEDICAL, INC.
2016-09-23
EndoSheath Technology - EndoSheath Technology for BRS-4000 Fiber Bronchoscope
COGENTIX MEDICAL, INC.
2016-09-23
EndoSheath Technology - EndoSheath Technology for BRS-4000 Fiber Bronchoscope
COGENTIX MEDICAL, INC.
2016-09-23
EndoSheath Technology - EndoSheath Technology for BRS-4000 Fiber Bronchoscope
COGENTIX MEDICAL, INC.
2016-09-23
EndoSheath Technology - EndoSheath Technology for BRS-4000 Fiber Bronchoscope
COGENTIX MEDICAL, INC.
2016-09-23
EndoSheath Technology - EndoSheath Technology for the TNE-5000 Video Esophagoscope
COGENTIX MEDICAL, INC.
2016-09-23
EndoSheath Technology - EndoSheath Technology for the TNE-5000 Video Esophagoscope
COGENTIX MEDICAL, INC.
2016-09-23
UNITY 9000 - UNITY 9000 Video Processor for use with Cogentix Medical video endoscopes
COGENTIX MEDICAL, INC.
2018-12-20
UNITY 9100 - UNITY 9100 Video Processor with Air Pump for use with Cogentix Medical video endoscopes
COGENTIX MEDICAL, INC.
2018-12-20
Video Processor - Digital Processing Unit - Reconditioned
COGENTIX MEDICAL, INC.
2016-09-22
Video Processor - Digital Processing Unit - Reconditioned
COGENTIX MEDICAL, INC.
2016-09-22
Video Processor - Digital Processing Unit with Integrated LCD Display and Air Insufflation
COGENTIX MEDICAL, INC.
2016-09-22
Video Processor - Digital Processing Unit with Integrated LCD Display and Air Insufflation
COGENTIX MEDICAL, INC.
2016-09-22
Nasal Cytology Brush - 07-9006
COGENTIX MEDICAL, INC.
2016-09-23
Endoscopic Cytology Brush - 07-9001
COGENTIX MEDICAL, INC.
2016-09-23
Flexible Fiber Laryngoscope, Standard Set Reconditioned - Reconditioned
COGENTIX MEDICAL, INC.
2016-09-22
Flexible Video Laryngoscope (NTSC) Reconditioned - Reconditioned
COGENTIX MEDICAL, INC.
2016-09-22
Flexible Video Laryngoscope (NTSC) Reconditioned - Reconditioned
COGENTIX MEDICAL, INC.
2016-09-22
Endoscopic Injection Needle - 07-9005
COGENTIX MEDICAL, INC.
2016-09-23
Flexible Video Laryngoscope (NTSC) - ENT-7000
COGENTIX MEDICAL, INC.
2016-09-22
Flexible Fiber Laryngoscope, Standard Set - ENT-4500
COGENTIX MEDICAL, INC.
2016-09-22
Flexible Fiber Bronchoscope - BRS-4000
COGENTIX MEDICAL, INC.
2016-09-22
Flexible Fiber Laryngoscope, Standard Set - ENT-4000
COGENTIX MEDICAL, INC.
2016-09-22

53 records. Showing 1-40. Next