KONAN MEDICAL, INC.

FDA Registration(s)#

Registration, FEI, Name table
Registration	FEI	Name	Status	Initial importer	Expiration year	Address
9680854	1000494121	KONAN MEDICAL, INC.	1	N	2026-01-01	10-29 MIYANISHI-CHO NISHINOMIYA Hyogo JP 662-0976

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration key	Listing key	Premarket submission	Device	Product code	Decision date
15361	1380627778	K203244	CellChek 20 rc	NFJ	2021-06-15
15361	1457905561	K191558	Konan Specular Microscope XVII	NQE	2020-03-26
15361	1036428180	K062763	NONCON ROBO PACHY F&A	NQE	2008-02-22
15361	2068364468	K040373	KERATO ANALYZER (EKA)	NQE	2004-03-19

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product code	Registration listing records	Latest decision
NQE	3	2020-03-26
NFJ	1	2021-06-15

PMN#

CellChek 20 Rc
2021-06-15
Konan Medical, Inc.
Konan Specular Microscope XVII
2020-03-26
Konan Medical, Inc.
KONAN SPECULAR MICROSCOPE XIV
2012-04-11
KONAN MEDICAL, INC.
IMAGE STORAGE SYSTEM, MODEL KSS-400
2009-01-22
KONAN MEDICAL, INC.
NONCON ROBO PACHY F&A
2008-02-22
KONAN MEDICAL, INC.
KERATO ANALYZER (EKA)
2004-03-19
KONAN MEDICAL, INC.
KONAN NONCON ROBO SPECULAR MICROSCOPE, MODELS SP 6000 AND SP 8000
1995-03-01
KONAN MEDICAL, INC.

GUDID#

NA - CellChek 20-1 PLUS
KONAN MEDICAL, INC.
2023-09-27
NA - CellChek 20-1
KONAN MEDICAL, INC.
2022-04-07
NA - CC 20 rc
KONAN MEDICAL, INC.
2021-06-25
NA - CellChek 20
KONAN MEDICAL, INC.
2020-04-02
NA - NSP
KONAN MEDICAL, INC.
2016-08-29
NA - NSPC
KONAN MEDICAL, INC.
2016-09-23
NA - CD-15
KONAN MEDICAL, INC.
2016-09-23
NA - Cellchek
KONAN MEDICAL, INC.
2016-09-23
N/A - POM
KONAN MEDICAL, INC.
2017-11-27