Astec Co L T D

FDA Filings

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

FDA Registration(s)

• Registration Number: 3007459332
• FEI Number: 3007459332
• Name: Donald J Luongo
• Owner & Operator: ASTEC CO., Ltd.
• Contact Address: 4-6-15 Minamizato, Shime ; Kasuya JP-40 Hukuoka 8112207 JP
• Official Correspondent:
  • Daisuke Karita
  • 81-92-9355585-x
• US Agent:
  • Donald J Luongo
  • ASTEC BIO USA INC
  • 781 7490734
  • oosafe-support@astec-bio.com
• Importing Logistics Registration:
  • Importer: ASTEC BIO USA Inc.
  • Address: 10 Keith Way, Suite 3 ; Hingham, MA 02043 UNITED STATES
• Registration Status: 1
• Initial Importer: N
• Registration Expiration: 2020-04-25
• Registration Address: 10 Keith Way Suite 3 ; Hingham, MA 02043 US
• Establishment Type: Complaint File Establishment per 21 CFR 820.198

FDA Filings

Device Company	Device	Date
GUDID 24580647510105 ASTEC CO.,LTD.	ASTEC IVF 60mm Culture Dish	2024-08-09
GUDID 24580647510099 ASTEC CO.,LTD.	ASTEC IVF 35mm Culture Dish	2024-08-09
GUDID 24580647510082 ASTEC CO.,LTD.	ASTEC IVF ICSI Dish	2024-08-09
GUDID 24580647510075 ASTEC CO.,LTD.	ASTEC IVF Center Well Dish	2024-08-09
GUDID 24580647510068 ASTEC CO.,LTD.	ASTEC IVF 4Well Dish	2024-08-09
GUDID 24580647510051 ASTEC CO.,LTD.	ASTEC IVF 4Well Dish	2024-08-09
GUDID 14580647510030 ASTEC CO.,LTD.	Embryo Grid	2022-10-10
PUB Donald J Luongo [ASTEC CO., Ltd.]	EC6S-120MD	2019-05-15

Related Finance Registrations

NCAGE Code	SV800	ASTEC CO., LTD
CAGE Code	SV800	ASTEC CO., LTD

U.S. Import Records [external site]

Import ID	Shipment	Cargo Description	Quantity
202009108407	Shanghai ,China (Mainland) -> Boston, Massachusetts	MACHINERY	16 PKG
2020073021059	Hakata,Japan -> Boston, Massachusetts	INCUBATOR GLASS SMALL WINDOWS BASE STAND BCSI SAFESENS TRACKPOD TRACKPOD SMART STATION MOT	17 PCS
202007148758	Hakata,Japan -> New York/Newark Area, Newark, New Jersey	INCUBATOR, SMART STATION, CLEAR VIEW FRONT EX TRA VIEW, MOTORIZED STAND, POP-UP DOORS, STER	24 PCS
202007139571	Hakata,Japan -> New York/Newark Area, Newark, New Jersey	INCUBATOR, SMART STATION, CLEAR VIEW FRONT EX TRA VIEW, MOTORIZED STAND, POP-UP DOORS, STER	24 PCS
2020042441027	Pusan,South Korea -> Los Angeles, California	CONTAINER FOR LIQUID NITROGEN HS CODE:8419.89	4 PKG
2018110145959	Pusan,South Korea -> Long Beach, California	CANISTER, REFRIG, HIGH CAPACUTY, AL. CASKS, DRUMS, CANES, BOXES HS CODE:7612.90	3 CTN