Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3045007758

FEI Number

3045007758

Entity Name

INTERNATIONAL HAOTIAN TECHNOLOGY CO., LTD.

City/State/Country

Xiamen Fujian, CN

Establishment Address

5F, Dream Achievement Garden, 286 Jinyuan West 3rd. Road, Jimei District, Xiamen Fujian 361022, CN

Establishment Type(s)

Export Device to the United States But Perform No Other Operation on Device,Manufacture Medical Device for Another Party (Contract Manufacturer),Manufacture Medical Device

Owner / Operator

International Haotian Technology Co., Ltd. (Owner Number: 10095555)

Owner / Operator Contact Address

5F, Dream Achievement Garden, 286 Jinyuan West 3rd. Road, Jimei District, Xiamen, CN-FJ 361022, CN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Biological sample cooler bag, Biological sample cooler box, Temperature controlled container Cooler bag, Cooler box, Medical cooler bag, Medical cooler box, Vaccines carrier, Medical transport box,

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
NNL	Container, Specimen Mailer And Storage, Temperature Controlled, Non-Sterile	Pathology	Class 1	864.3250	2026-03-30

Official Correspondent

WENJING OU

US Agent Details

Leeyeo Kee Business: Regrek LLC Email: regrek.cs@hotmail.com Phone: (302) 6089028

Related Public Records

Same Entity

International Haotian Technology 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 3045007758. Last updated year: 2026. Please use registration number 3045007758 when referencing this establishment in official correspondence.