Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3007459332

FEI Number

3007459332

Entity Name

ASTEC CO., Ltd.

City/State/Country

Kasuya Fukuoka, JP

Establishment Address

4-6-15 Minamizato, Shime, Kasuya Fukuoka 8112207, JP

Establishment Type(s)

Develop Specifications But Do Not Manufacture At This Facility,Complaint File Establishment per 21 CFR 820.198

Owner / Operator

ASTEC Co., Ltd. (Owner Number: 10060470)

Owner / Operator Contact Address

4-6-15 Minamizato, Shime, Kasuya, JP-40 8112207, JP

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

EC10-120MD EC6S-120MD Embryo Grid ASTEC IVF 35mm Culture Dish ASTEC IVF Center Well Dish ASTEC IVF ICSI Dish ASTEC IVF 4Well Dish, Model Number AID-4W ASTEC IVF 4Well Dish, Model Number AID-4WH ASTEC IVF 60mm Culture Dish

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
PUB	Accessory, Assisted Reproduction, Exempt	Obstetrics/Gynecology	Class 2	884.6120	2019-05-15
PUD	Labware, Assisted Reproduction, Exempt	Obstetrics/Gynecology	Class 2	884.6160	2022-06-13

Official Correspondent

No official correspondent registered.

US Agent Details

Donald J Luongo Business: Astec Bio USA, Inc. Email: oosafe-support@astec-bio.com Phone: (781) 7490734

Related Public Records

Same Entity

ASTEC Co., Ltd.

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3007459332. Last updated year: 2026. Please use registration number 3007459332 when referencing this establishment in official correspondence.