Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3038311113

FEI Number

3038311113

Entity Name

SHENZHEN BAIRUNHENG TECHNOLOGY CO., LTD.

City/State/Country

shenzhen Guangdong, CN

Establishment Address

Room 602, Building 425, Bagualing Industrial Zone, 41 Bagua 4th Road, Hualin Community, Yuanling Subdistrict, Futian District, Shenzhen,CN, shenzhen Guangdong 518000, CN

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

Shenzhen Bairunheng Technology Co., Ltd. (Owner Number: 10093258)

Owner / Operator Contact Address

Room 602, Building 425, Bagualing Industrial Zone, 41 Bagua 4th Road, Hualin Community, Yuanling Subdistrict, Futian District, Shenzhen,CN, shenzhen, CN-GD 518000, CN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Orthodontic Brackets;Model:16159542 Fixed catheter;Model:12380517;13700978;16842867;18634303; 10 PCS Practical Plastic Specimen Cup Stool Container 25-30ml without Label Laboratory Medical Use;Model:3999851 10 PCS Practical Plastic Specimen Cup Stool Container 25-30ml without Label Laboratory Medical Use Meridian massage;Model:17621590

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
EJF	Bracket, Metal, Orthodontic	Dental	Class 1	872.5410	2025-04-21
BSY	Catheters, Suction, Tracheobronchial	Anesthesiology	Class 1	868.6810	2025-04-21
FMH	Container, Specimen, Sterile	Pathology	Class 1	864.3250	2026-05-04
NNK	Container, Specimen Mailer And Storage, Non-Sterile	Pathology	Class 1	864.3250	2026-05-04
LYG	Massager, Therapeutic, Manual	Physical Medicine	Class 1	890.5660	2025-04-21

Official Correspondent

Fang liu

US Agent Details

mark DU Business: AZUR US Limited Email: markFDA@outlook.com Phone: (719) 2013314

Related Public Records

Same Entity

Shenzhen Bairunheng Technology Co., Ltd.

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
K894358	Ormco Corp.	LUMINA ORTHODONTIC BRACKET	1989-09-15
K925012	American Orthodontics	PLASTIC CHAIN	1993-09-13

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3027343382	UNIVY TECHNOLOGY ADVANCED CO. LTD	Shanghai, CN
3023443842	HENAN BAISTRA MEDICAL DEVICES LIMITED	Zhengzhou Henan, CN
3012232878	SUNSTAR TRADING INTERNATIONAL LIMITED	Kowloon Hong Kong, CN

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3038311113. Last updated year: 2026. Please use registration number 3038311113 when referencing this establishment in official correspondence.