BRACEUS INDUSTRIES CO., LIMITED

FDA Device Registration & Listing · HK, HK · Registration 3044854651

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
3044854651
FEI Number
3044854651
Entity Name
BRACEUS INDUSTRIES CO., LIMITED
City/State/Country
HK, HK
Establishment Address
UNIT 1021, BEVERLEY COMMERCIAL CENTRE, 87-105 CHATHAM ROAD SOUTH, TSIM SHA TSUI, HK, HK 999077, HK
Establishment Type(s)
Export Device to the United States But Perform No Other Operation on Device
Owner / Operator
BRACEUS INDUSTRIES CO., LIMITED (Owner Number: 10095757)
Owner / Operator Contact Address
UNIT 1021, BEVERLEY COMMERCIAL CENTRE, 87-105 CHATHAM ROAD SOUTH, TSIM SHA TSUI, HK, HK, HK-NOTA 999077, HK
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
N/A
PMA Number
N/A

All Registered Proprietary Names

ORTHOSIS, CERVICAL ORTHOSIS, LIMB BRACE ORTHOSIS, ABDOMINAL SLING, ARM ORTHOSIS, TRUNCAL/ORTHOSIS, LIMB Tape and Bandage, adhesive STOCKING, MEDICAL SUPPORT Elbow Support SPLINT, HAND, AND COMPONENTS JOINT, ANKLE, EXTERNAL BRACE Ankle Support

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
IQK Orthosis, Cervical Physical Medicine Class 1 890.3490 2026-04-24
IQI Orthosis, Limb Brace Physical Medicine Class 1 890.3475 2026-04-24
KTD Orthosis, Abdominal Physical Medicine Class 1 890.3490 2026-04-24
ILI Sling, Arm Physical Medicine Class 1 890.3640 2026-04-24
MRI Orthosis, Truncal/Orthosis, Limb Physical Medicine Class 1 890.3490 2026-04-24
KGX Tape And Bandage, Adhesive General Hospital Class 1 880.5240 2026-06-09
FQL Stocking, Medical Support (For General Medical Purposes) General Hospital Class 1 880.5780 2026-04-24
ILH Splint, Hand, And Components Physical Medicine Class 1 890.3475 2026-04-24
ITW Joint, Ankle, External Brace Physical Medicine Class 1 890.3475 2026-04-24

Official Correspondent

ADA JI

US Agent Details

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

Related Public Records

Same Entity

BRACEUS INDUSTRIES CO., LIMITED
View consolidated registration, premarket clearance, and recall records for this applicant.
View Entity Profile →

Related 510(k) Records

510(k) Number Applicant Device Name Decision Date
K843874 Beiersdorf, Inc. LEUKOPOR SURGICAL TAPE 1985-02-21
K915446 Sun Glitz Corp. STRETCH WRAP 1992-05-06
K833120 Acme United Corp. ONE TIME COMPOUND BENZOIN TINCTURE- 1983-12-29
K870091 Avery Intl. IV SECUREMENT DEVICE USING PCCE THERMO. FILM 1987-02-04

Related Recall Records

Recall ID Recalling Firm Recall Class Product Description
Z-0006-2025 Ossur H F Grjothals 5 Reykjavik Iceland 1
Miami J Select Collar, Catalog: MJS-101; Miami J Select Collar Set, Catalog: MJSR-101

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3044854651. Last updated year: 2026. Please use registration number 3044854651 when referencing this establishment in official correspondence.
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