Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3002857192

FEI Number

3002857192

Entity Name

Rex Enterprises Co., Ltd.

City/State/Country

Nakhon Pathom City, TH

Establishment Address

37/6 Moo 1, Thakham, Samphran, Nakhon Pathom City 73160, TH

Establishment Type(s)

Export Device to the United States But Perform No Other Operation on Device,Manufacture Medical Device

Owner / Operator

Leda Innovations USA Inc. (Owner Number: 10095686)

Owner / Operator Contact Address

99 Pond Avenue, #718, Brookline, MA 02445, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Rex Enterprises Co., Ltd. Rex Enterprises Co., Ltd. Rex Enterprises Co., Ltd.

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
HGY	Pump, Breast, Non-Powered	Obstetrics/Gynecology	Class 1	884.5150	2026-04-14
KKO	Ring, Teething, Fluid-Filled	Dental	Class 2	872.5550	2026-04-14
MEF	Ring, Teething, Non-Fluid Filled	Dental	Class 1	872.5550	2026-04-14

Official Correspondent

Fanny Chan

US Agent Details

Fanny Chan Business: Leda Innovations USA Inc. Email: fanny@ledahealth.ca Phone: (508) 2311189

Related Public Records

Same Entity

Leda Innovations USA Inc.

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 3002857192. Last updated year: 2026. Please use registration number 3002857192 when referencing this establishment in official correspondence.