Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3006434267

FEI Number

3006434267

Entity Name

BAIMTEC MATERIAL CO., LTD.

City/State/Country

BEIJING, CN

Establishment Address

Huanshan Village, Haidian District,, BEIJING 100095, CN

Establishment Type(s)

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

Owner / Operator

BAIMTEC MATERIAL CO., LTD. (Owner Number: 9101079)

Owner / Operator Contact Address

No5, Yongxiang North Road, Yongfeng Industry Park, Haidian District, BEIJING, CN-BJ 100094, CN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

AFO DYNAMIC AFO LIGHT

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
IQI	Orthosis, Limb Brace	Physical Medicine	Class 1	890.3475	2007-05-01

Official Correspondent

Sen BAI

US Agent Details

Katla Axelsdottir Business: Ossur Email: kaxelsdottir@ossur.com Phone: (949) 3823833

Related Public Records

Same Entity

BAIMTEC MATERIAL 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 3006434267. Last updated year: 2026. Please use registration number 3006434267 when referencing this establishment in official correspondence.