Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3015554544

FEI Number

3015554544

Entity Name

ELASTOMERIX VIETNAM CO. LTD

City/State/Country

Ho Chi Minh City Binh Duong, VN

Establishment Address

Lot CN15, Box No. 10, Street No. 6, SongThan 3 Industrial Park, Binh Duong Ward, Ho Chi Minh City Binh Duong 75350, VN

Establishment Type(s)

Manufacture Medical Device for Another Party (Contract Manufacturer)

Owner / Operator

Elastomerix Vietnam Co. Ltd (Owner Number: 10079185)

Owner / Operator Contact Address

Lot CN15, Box No. 10, Street No. 6, SongThan 3 Industrial Park, Binh Duong Ward, Ho Chi Minh City, VN-57 75350, VN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

No proprietary names listed under this establishment.

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
IOD	Components, Exercise	Physical Medicine	Class 1	890.5350	2021-02-04
ILT	Adaptor, Recreational	Physical Medicine	Class 1	890.5050	2020-11-23

Official Correspondent

Jacky Wang

US Agent Details

Richard Donnell Business: Implus Footcare, LLC Email: rdonnell@4implus.com Phone: (919) 3141923

Related Public Records

Same Entity

Elastomerix Vietnam 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 3015554544. Last updated year: 2026. Please use registration number 3015554544 when referencing this establishment in official correspondence.