Boditech Med Inc

FDA Filings

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

KOREA REP OF

KOREA EXCHANGE (KOSDAQ)

206640

DUNS 689062203

FDA Registration(s)

• Registration Number: 3009491259
• FEI Number: 3009491259
• Name: BODITECH MED INC.
• Owner & Operator: Boditech Med Inc.
• Contact Address: 43, Geodudanji 1-gil, Dongnae-myeon ; Chuncheon KR-42 Gangweondo 24398 KR
• Official Correspondent:
  • Hyung-Ju Oh
  • 82-33-2431400-x
• US Agent:
  • Andrea Geffon
  • Immunostics Inc.
  • 732 9180770
  • 732 9180618
  • ageffon@immunostics.com
• Registration Status: 1
• Initial Importer: N
• Registration Expiration: 2020-04-25
• Registration Address: 43, Geodudanji 1-gil, Dongnae-myeon ; Chuncheon Gangweondo, 24398 KR
• Establishment Type:
  • Manufacture Medical Device
  • Manufacture Medical Device for Another Party (Contract Manufacturer)

FDA Filings

Device Company	Device	Date
GUDID 08806133080849 Boditech Med Inc.	Swab-N-Go Home Test COVID-19 Ag	2023-10-18
GUDID 08806133010068 Boditech Med Inc.	AFIAS-50 FPRR022	2022-09-16
GUDID 08806133010099 Boditech Med Inc.	ichroma Reader FPRR001	2022-06-10
GUDID 08806133010136 Boditech Med Inc.	ALFIS-3 FPRR028	2021-12-14
GUDID 08806679002718 Boditech Med Inc.	ichroma™ iFOB CFPC-15	2020-06-17
GUDID 08806679001520 Boditech Med Inc.	ichroma™ CRP i-CHOMRA CRP-25	2020-06-17
GUDID 08806133005279 Boditech Med Inc.	AFIAS TSH-VB SMFP-58	2020-06-17
GUDID 08806133005262 Boditech Med Inc.	AFIAS TSH-SP SMFP-57	2020-06-17
QKO BODITECH MED INC.	ichroma? COVID-19 Ab with ichroma? II Analyzer	2020-04-05
QKO BODITECH MED INC.	AFIAS COVID-19 Ab with AFIAS-6 Analyzer	2020-04-05
QKO BODITECH MED INC.	AFIAS COVID-19 Ab with AFIAS-1 Analyzer	2020-04-05
GUDID 08806133010075 Boditech Med Inc.	AFIAS-6/SP Analyzer FPRR020-4	2019-12-13
GUDID 08806133005255 Boditech Med Inc.	AFIAS iFOB with AFIAS-50 CFPO-15-1	2019-12-13
GUDID 00886133010075 Boditech Med Inc.	AFIAS-6/SP Analyzer FPRR020-4	2018-07-06
GUDID 00880613305255 Boditech Med Inc.	AFIAS iFOB with AFIAS-50 CFPO-15-1	2018-03-29
PMN K170232 | KHO BODITECH MED INC.	AFIAS TSH with AFIAS-6 Analyzer	2017-10-25
PMN K170232 | JLW BODITECH MED INC.	AFIAS TSH with AFIAS-6 Analyzer	2017-10-25
PMN K170232 BODITECH MED INC.	AFIAS TSH-SP, AFIAS TSH-VB, AFIAS-6/SP Analyzer, AFIAS-6/VB Analyzer	2017-10-13
PMN K062981 | DCN BODITECH MED INC.	Boditech Med Inc.	2016-06-16
PMN K132167 | OOX BODITECH MED INC.	ichroma	2014-05-12
PMN K132167 | OOX BODITECH MED INC.	Boditech Med Inc.	2014-05-12
PMN K132167 | JJX BODITECH MED INC.	ichroma	2014-05-12
PMN K132167 | JJX BODITECH MED INC.	Boditech Med Inc.	2014-05-12
PMN K132167 Boditech Med Inc.	I-CHROMA IFOB WITH I-CHROMA READER	2014-05-02

U.S. Import Records [external site]

Import ID	Shipment	Cargo Description	Quantity
2020070638142	Pusan,South Korea -> Long Beach, California	PREPARATIONS OF BLOOD FRACTIONS AND MEDICATIO	329 CTN
2020050520579	Pusan,South Korea -> New York/Newark Area, Newark, New Jersey	MICROTOMES PARTS AND ACCESSORIES HS CODE 9027 90	106 CTN
2020030525095	Pusan,South Korea -> Long Beach, California	MICROTOMES PARTS AND ACCESSORIES HS CODE 9027 90	78 CTN
2019082714279	Pusan,South Korea -> New York/Newark Area, Newark, New Jersey	MICROTOMES PARTS AND ACCESSORIES HS CODE 9027 90	113 CTN
2019032021901	Pusan,South Korea -> New York/Newark Area, Newark, New Jersey	MICROTOMES PARTS AND ACCESSORIES HS CODE 9027 90	29 CTN
2018060222719	Pusan,South Korea -> New York/Newark Area, Newark, New Jersey	MICROTOMES PARTS AND ACCESSORIES HS CODE 3822 00	193 CTN