Diagnosys L L C

FDA Filings

This page includes the latest FDA filings for Diagnosys L L C. Currently, you will find the latest 100 filings for Premarket Notifications, Premarket Applications, De Novo Applications, and GUDID registrations.

FDA Registration(s)

• Registration Number: 1221363
• FEI Number: 1221363
• Name: DORAN INSTRUMENTS, INC.D/B/A DIAGNOSYS LLC
• Owner & Operator: DIAGNOSYS LLC
• Contact Address: 55 Technology Drive Suite 100; Lowell MA 01851 US
• Official Correspondent:
  • ANNE C DORAN
  • x-978-4581600-111
• Registration Status: 1
• Initial Importer: N
• Registration Expiration: 2020-04-25
• Registration Address: 55 TECHNOLOGY DR STE 100 ; Lowell, MA 01851 US
• Establishment Type: Manufacture Medical Device

FDA Filings

Device Company	Device	Date
GUDID 10855730007426 DIAGNOSYS LLC	DTL 2 D141	2024-11-19
GUDID 00850594007004 DIAGNOSYS LLC	Standalone	2023-06-09
GUDID 00855730007337 DIAGNOSYS LLC	Gold Lens D102	2021-05-04
GUDID 00855730007320 DIAGNOSYS LLC	Gold Lens D101	2021-05-04
GUDID 00855730007313 DIAGNOSYS LLC	Espion	2021-05-04
GUDID 00855730007306 DIAGNOSYS LLC	Espion	2021-05-04
GUDID 00855730007290 DIAGNOSYS LLC	Espion	2021-05-04
GUDID 00855730007283 DIAGNOSYS LLC	Espion	2021-04-21
GUDID 00855730007276 DIAGNOSYS LLC	Espion	2021-04-21
GUDID 00855730007269 DIAGNOSYS LLC	Espion	2021-04-16
GUDID 00855730007252 DIAGNOSYS LLC	Espion	2020-12-10
GUDID 00855730007245 DIAGNOSYS LLC	Espion	2020-08-05
GUDID 00855730007238 DIAGNOSYS LLC	Espion	2020-04-24
GUDID 00855730007221 DIAGNOSYS LLC	Espion	2020-03-26
GUDID 00855730007214 DIAGNOSYS LLC	Espion	2020-02-19
GUDID 00855730007207 DIAGNOSYS LLC	Espion	2020-02-04
GUDID 00855730007191 DIAGNOSYS LLC	Espion	2019-10-28
GUDID 00855730007184 DIAGNOSYS LLC	Espion	2019-09-27
GUDID 00855730007177 DIAGNOSYS LLC	Espion	2019-09-27
GUDID 00850594007554 DIAGNOSYS LLC	Espion	2019-08-13
GUDID 00855730007122 DIAGNOSYS LLC	Espion	2019-02-26
GUDID 00855730007153 DIAGNOSYS LLC	Espion	2019-02-15
GUDID 00850594007158 DIAGNOSYS LLC	Espion	2019-01-16
GUDID 00855730007146 DIAGNOSYS LLC	Espion	2018-12-17
GUDID 00855730007139 DIAGNOSYS LLC	Espion	2018-12-03
GUDID 00850594007127 DIAGNOSYS LLC	Espion	2018-09-05
GUDID 00850594007776 DIAGNOSYS LLC	Espion	2018-07-06
GUDID 00850594007769 DIAGNOSYS LLC	Espion	2018-07-06
GUDID 00850594007752 DIAGNOSYS LLC	Espion	2018-07-06
GUDID 00850594007745 DIAGNOSYS LLC	Espion	2018-07-06
GUDID 00850594007738 DIAGNOSYS LLC	Espion	2018-07-06
GUDID 00850594007721 DIAGNOSYS LLC	Espion	2018-07-06
GUDID 00850594007714 DIAGNOSYS LLC	Espion	2018-07-06
GUDID 00850594007707 DIAGNOSYS LLC	Espion	2018-07-06
GUDID 00850594007691 DIAGNOSYS LLC	Espion	2018-07-06
GUDID 00850594007684 DIAGNOSYS LLC	Espion	2018-07-06
GUDID 00850594007677 DIAGNOSYS LLC	Espion	2018-07-06
GUDID 00850594007660 DIAGNOSYS LLC	Espion	2018-07-06
GUDID 00850594007653 DIAGNOSYS LLC	Espion	2018-07-06
GUDID 00850594007646 DIAGNOSYS LLC	Espion	2018-07-06
GUDID 00850594007639 DIAGNOSYS LLC	Espion	2018-07-06
GUDID 00850594007622 DIAGNOSYS LLC	Espion	2018-07-06
GUDID 00850594007615 DIAGNOSYS LLC	Espion	2018-07-06
GUDID 00850594007608 DIAGNOSYS LLC	Espion	2018-07-06
GUDID 00850594007592 DIAGNOSYS LLC	Espion	2018-07-06
GUDID 00850594007585 DIAGNOSYS LLC	Espion	2018-07-06
GUDID 00850594007578 DIAGNOSYS LLC	Espion	2018-07-06
GUDID 00850594007561 DIAGNOSYS LLC	Espion	2018-07-06
GUDID 00850594007547 DIAGNOSYS LLC	Espion	2018-07-06
GUDID 00850594007530 DIAGNOSYS LLC	Espion	2018-07-06
GUDID 00850594007523 DIAGNOSYS LLC	Espion	2018-07-06
GUDID 00850594007516 DIAGNOSYS LLC	Espion	2018-07-06
GUDID 00850594007509 DIAGNOSYS LLC	Espion	2018-07-06
GUDID 00850594007493 DIAGNOSYS LLC	Espion	2018-07-06
GUDID 00850594007486 DIAGNOSYS LLC	Espion	2018-07-06
GUDID 00850594007479 DIAGNOSYS LLC	Espion	2018-07-06
GUDID 00850594007462 DIAGNOSYS LLC	Espion	2018-07-06
GUDID 00850594007455 DIAGNOSYS LLC	Espion	2018-07-06
GUDID 00850594007448 DIAGNOSYS LLC	Espion	2018-07-06
GUDID 00850594007431 DIAGNOSYS LLC	Espion	2018-07-06
GUDID 00850594007424 DIAGNOSYS LLC	Espion	2018-07-06
GUDID 00850594007417 DIAGNOSYS LLC	Espion	2018-07-06
GUDID 00850594007400 DIAGNOSYS LLC	Espion	2018-07-06
GUDID 00850594007394 DIAGNOSYS LLC	Espion	2018-07-06
GUDID 00850594007387 DIAGNOSYS LLC	Espion	2018-07-06
GUDID 00850594007370 DIAGNOSYS LLC	Espion	2018-07-06
GUDID 00850594007363 DIAGNOSYS LLC	Espion	2018-07-06
GUDID 00850594007356 DIAGNOSYS LLC	Espion	2018-07-06
GUDID 00850594007349 DIAGNOSYS LLC	Espion	2018-07-06
GUDID 00850594007332 DIAGNOSYS LLC	Espion	2018-07-06
GUDID 00850594007325 DIAGNOSYS LLC	Espion	2018-07-06
GUDID 00850594007318 DIAGNOSYS LLC	Espion	2018-07-06
GUDID 00850594007301 DIAGNOSYS LLC	Espion	2018-07-06
GUDID 00850594007295 DIAGNOSYS LLC	Espion	2018-07-06
GUDID 00850594007288 DIAGNOSYS LLC	Espion	2018-07-06
GUDID 00850594007271 DIAGNOSYS LLC	Espion	2018-07-06
GUDID 00850594007264 DIAGNOSYS LLC	Espion	2018-07-06
GUDID 00850594007257 DIAGNOSYS LLC	Espion	2018-07-06
GUDID 00850594007240 DIAGNOSYS LLC	Espion	2018-07-06
GUDID 00850594007233 DIAGNOSYS LLC	Espion	2018-07-06
GUDID 00850594007226 DIAGNOSYS LLC	Espion	2018-07-06
GUDID 00850594007219 DIAGNOSYS LLC	Espion	2018-07-06
GUDID 00850594007202 DIAGNOSYS LLC	Espion	2018-07-06
GUDID 00850594007196 DIAGNOSYS LLC	Espion	2018-07-06
GUDID 00850594007189 DIAGNOSYS LLC	Espion	2018-07-06
GUDID 00850594007172 DIAGNOSYS LLC	Espion	2018-07-06
GUDID 00850594007165 DIAGNOSYS LLC	Espion	2018-07-06
GUDID 00850594007141 DIAGNOSYS LLC	Espion	2018-07-06
GUDID 00850594007134 DIAGNOSYS LLC	Espion	2018-07-06
GUDID 00850594007110 DIAGNOSYS LLC	Espion	2018-07-06
GUDID 00850594007103 DIAGNOSYS LLC	Espion	2018-07-06
GUDID 00850594007097 DIAGNOSYS LLC	Espion	2018-07-06
GUDID 00850594007080 DIAGNOSYS LLC	Espion	2018-07-06
GUDID 00850594007073 DIAGNOSYS LLC	Espion	2018-07-06
GUDID 00850594007066 DIAGNOSYS LLC	Espion	2018-07-06
GUDID 00850594007059 DIAGNOSYS LLC	Espion	2018-07-06
GUDID 00850594007042 DIAGNOSYS LLC	Espion	2018-07-06
GUDID 00850594007035 DIAGNOSYS LLC	Espion	2018-07-06
GUDID 00850594007028 DIAGNOSYS LLC	Espion	2018-07-06
GUDID 00850594007011 DIAGNOSYS LLC	DTL D141	2018-07-06
PMN K913239 | HLZ DORAN INSTRUMENTS, INC.D/B/A DIAGNOSYS LLC [DIAGNOSYS LLC]	GoldLens	2010-02-22
PMN K913239 | HLZ DORAN INSTRUMENTS, INC.D/B/A DIAGNOSYS LLC [DIAGNOSYS LLC]	DTL Plus Electrode	2010-02-22
PMN K863956 | GWE DORAN INSTRUMENTS, INC.D/B/A DIAGNOSYS LLC [DIAGNOSYS LLC]	StandAlone Controller	2010-02-22
PMN K863956 | GWE DORAN INSTRUMENTS, INC.D/B/A DIAGNOSYS LLC [DIAGNOSYS LLC]	Pattern Stimulator Generator (PSG)	2010-02-22
PMN K863956 | GWE DORAN INSTRUMENTS, INC.D/B/A DIAGNOSYS LLC [DIAGNOSYS LLC]	MaculoScope	2010-02-22
PMN K863956 | GWE DORAN INSTRUMENTS, INC.D/B/A DIAGNOSYS LLC [DIAGNOSYS LLC]	Espion	2010-02-22
PMN K863956 | GWE DORAN INSTRUMENTS, INC.D/B/A DIAGNOSYS LLC [DIAGNOSYS LLC]	Espion Profile System	2010-02-22
PMN K863956 | GWE DORAN INSTRUMENTS, INC.D/B/A DIAGNOSYS LLC [DIAGNOSYS LLC]	Espion Profile Multifocal	2010-02-22
PMN K863956 | GWE DORAN INSTRUMENTS, INC.D/B/A DIAGNOSYS LLC [DIAGNOSYS LLC]	Espion E3 Electroretinography Console	2010-02-22
PMN K863956 | GWE DORAN INSTRUMENTS, INC.D/B/A DIAGNOSYS LLC [DIAGNOSYS LLC]	Espion E2 Electroretinography Console	2010-02-22
PMN K863956 | GWE DORAN INSTRUMENTS, INC.D/B/A DIAGNOSYS LLC [DIAGNOSYS LLC]	Envoy	2010-02-22
PMN K863956 | GWE DORAN INSTRUMENTS, INC.D/B/A DIAGNOSYS LLC [DIAGNOSYS LLC]	Desktop Envoy	2010-02-22
PMN K863956 | GWE DORAN INSTRUMENTS, INC.D/B/A DIAGNOSYS LLC [DIAGNOSYS LLC]	D382ColorFlash -Handheld Flash Stimulator	2010-02-22
PMN K863956 | GWE DORAN INSTRUMENTS, INC.D/B/A DIAGNOSYS LLC [DIAGNOSYS LLC]	ColorDome Ganzfeld Stimulator	2010-02-22
PMN K863956 | GWE DORAN INSTRUMENTS, INC.D/B/A DIAGNOSYS LLC [DIAGNOSYS LLC]	ColorBurst Handheld Ganzfeld Stimulator	2010-02-22

Related Finance Registrations

NCAGE Code	1E3M2	DIAGNOSYS LLC
CAGE Code	1E3M2	DIAGNOSYS LLC
S.A.M. Registration	1E3M2 [131488467]	DIAGNOSYS LLC
DUNS	131488467	Diagnosys LLC

U.S. Import Records [external site]

Import ID	Shipment	Cargo Description	Quantity
2020050715442	Shanghai ,China (Mainland) -> Boston, Massachusetts	INSTRUMENT TABLE BASE	20 CTN
201806147637	Shanghai ,China (Mainland) -> Boston, Massachusetts	INSTRUMENT TABLE BASE	1 CTN
201803089851	Shanghai ,China (Mainland) -> Boston, Massachusetts	INSTRUMENT TABLE BASE	20 CTN