BRADACARE (XIAMEN) HEALTH TECHNOLOGY CO.,LTD

FDA Device Registration & Listing · Xiamen City Fujian, CN · Registration 3027332487

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
3027332487
FEI Number
3027332487
Entity Name
BRADACARE (XIAMEN) HEALTH TECHNOLOGY CO.,LTD
City/State/Country
Xiamen City Fujian, CN
Establishment Address
No.1368, Jicheng Road, Tong'an Area, Xiamen City Fujian 361100, CN
Establishment Type(s)
Export Device to the United States But Perform No Other Operation on Device,Manufacture Medical Device,Manufacture Medical Device for Another Party (Contract Manufacturer)
Owner / Operator
Bradacare (XiaMen) Health Technology Co.,LTD (Owner Number: 10087685)
Owner / Operator Contact Address
No.1368, Jicheng Road, Tong'an Area, Xiamen City, CN-FJ 361100, CN
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
N/A
PMA Number
N/A

All Registered Proprietary Names

Rollator Walker, BR808S, BR808S-1, BR808S-2, BR808S-3, BR808S-5, BR818, BR818-1, BR818-2, BR818-3, BR818-5, BR818S, BR818S-1, BR818S-2, BR0001/BR0001-1/BR0001-2/BR0001-3, BR0002/BR0002-1/BR0002-2/BR0002-3, BR0003/BR0003-1/BR0003-2/BR0003-3, BR0006/BR0006-1/BR0006-2/BR0006-3/BR0006-5/BR0006-6, BR0006S, BR0006S-1, BR0006S-2, BR0006S-3, BR0006S-5, BR0006S-5, BR818S-3, BR818S-5, BR818S-6, BR828, BR828-1, BR828-2, BR828-3, BR828-5, BR828-6 BR0005/BR0005-1/BR0005-2/BR0005-3, BR0005PLUS, BR0005PLUS-1, BR0005PLUS-2, BR0005PLUS-3, BR0005PLUS-5, BR0006F/BR0006F-1/BR0006F-2/BR0006F-3/BR0006F-5/BR0006F-6, BR0006FS/BR0006FS-1/BR0006FS-2/BR0006FS-3/BR0006FS-5/BR0006FS-6, BR808, BR808-1, BR808-2, BR808-3, BR808-5, BR808-6,

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
ITJ Walker, Mechanical Physical Medicine Class 1 890.3825 2023-03-27

Official Correspondent

Hao Liu

US Agent Details

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

Related Public Records

Same Entity

Bradacare (XiaMen) Health Technology Co.,LTD
View consolidated registration, premarket clearance, and recall records for this applicant.
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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3027332487. Last updated year: 2026. Please use registration number 3027332487 when referencing this establishment in official correspondence.
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