Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3023443842

FEI Number

3023443842

Entity Name

HENAN BAISTRA MEDICAL DEVICES LIMITED

City/State/Country

Zhengzhou Henan, CN

Establishment Address

80 DIANCHANG RD, BUILDING 162, FLOOR 20, SUITE 61, HI-TECH INDUSTRIES DEVELOPMENT,, Zhengzhou Henan 450000, CN

Establishment Type(s)

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

Owner / Operator

HENAN BAISTRA MEDICAL DEVICES LIMITED (Owner Number: 10085746)

Owner / Operator Contact Address

80 DIANCHANG RD, BUILDING 162, FLOOR 20, SUITE 61, HI-TECH INDUSTRIES DEVELOPMENT,, Zhengzhou, CN-HA 450000, CN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Polishing Strip Dental Operating Light Dispenser, solid medication BRACKET, METAL, ORTHODONTIC BLADE, SCALPEL MIRROR, MOUTH INSTRUMENT, FILLING, PLASTIC, DENTAL Mouthpiece, saliva ejector INSTRUMENTS, DENTAL HAND WHEEL, POLISHING AGENT WAX, DENTAL, INTRAORAL GUTTA-PERCHA TUBE, ORTHODONTIC PAPER, ARTICULATION SYRINGE, RESTORATIVE AND IMPRESSION MATERIA Barrier Film Barrier Covers CHAIR, ADJUSTABLE, MECHANICAL CLAMP, WIRE, ORTHODONTIC Dental Trolley Cart FILE, PULP CANAL, ENDODONTIC TRAY, SURGICAL, INSTRUMENT ACCESSORIES, RETRACTOR, DENTAL BUR, DENTAL

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
EHM	Strip, Polishing Agent	Dental	Class 1	872.6010	2025-02-07
EAZ	Light, Operating, Dental	Dental	Class 1	872.4630	2025-02-21
NXB	Dispenser, Solid Medication	Physical Medicine	Class 1	890.5050	2026-04-26
EJF	Bracket, Metal, Orthodontic	Dental	Class 1	872.5410	2022-07-28
GES	Blade, Scalpel	General, Plastic Surgery	Class 1	878.4800	2026-04-22
EAX	Mirror, Mouth	Dental	Class 1	872.4565	2026-04-13
EIY	Instrument, Filling, Plastic, Dental	Dental	Class 1	872.4565	2022-07-28
DYN	Mouthpiece, Saliva Ejector	Dental	Class 1	872.6640	2025-12-19
DZN	Instruments, Dental Hand	Dental	Class 1	872.4565	2025-12-19
EJQ	Wheel, Polishing Agent	Dental	Class 1	872.6010	2025-12-19
EGD	Wax, Dental, Intraoral	Dental	Class 1	872.6890	2026-04-22
EKM	Gutta-Percha	Dental	Class 1	872.3850	2022-07-28
DZD	Tube, Orthodontic	Dental	Class 1	872.5410	2022-07-28
EFH	Paper, Articulation	Dental	Class 1	872.6140	2026-04-22
EID	Syringe, Restorative And Impression Material	Dental	Class 1	872.4565	2025-12-19
FRK	Chair, Examination And Treatment	General Hospital	Class 1	880.6140	2025-06-18
INN	Chair, Adjustable, Mechanical	Physical Medicine	Class 1	890.3100	2022-07-28
ECN	Clamp, Wire, Orthodontic	Dental	Class 1	872.5410	2022-07-28
BZN	Cart, Emergency, Cardiopulmonary (Excluding Equipment)	Anesthesiology	Class 1	868.6175	2025-01-12
EKS	File, Pulp Canal, Endodontic	Dental	Class 1	872.4565	2022-07-28
FSM	Tray, Surgical, Instrument	General, Plastic Surgery	Class 1	878.4800	2025-12-19
EIF	Accessories, Retractor, Dental	Dental	Class 1	872.4565	2022-07-28
EJL	Bur, Dental	Dental	Class 1	872.3240	2022-07-28

Official Correspondent

Ya Li

US Agent Details

Felix Fan Email: ipr@baistra.com Phone: (626) 6653973

Related Public Records

Same Entity

HENAN BAISTRA MEDICAL DEVICES 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
K944481	Garan Scientific, Inc.	THE HEART PROTECTOR	1995-04-10
K894358	Ormco Corp.	LUMINA ORTHODONTIC BRACKET	1989-09-15
K925012	American Orthodontics	PLASTIC CHAIN	1993-09-13
K781592	Henry Schein, Inc.	SURGICAL ASPIRATOR TIPS	1978-12-04
K864976	Endo Technic Corp.	SOLUSET CALCIUM DEMINERALIZING SOLUTION	1987-02-27

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0012-2008	Becton Dickinson & Company	1	Shelf Pack: Bard-Parker Rib-Back Carbon Steel no.11, surgical blade. Unit Package: Contents of unopened or undamaged package guaranteed sterile; After use place product in a puncture resistant container and dispose properly. Becton Dickinson Becton Dickinson Acute Care Franklin Lakes, NJ 07417
Z-0013-2008	Becton Dickinson & Company	1	Shelf Pack: Bard-Parker Rib-Back Stainless Steel no.11, surgical blade. Unit Package: Contents of unopened or undamaged package guaranteed sterile; After use place product in a puncture resistant container and dispose properly. Becton Dickinson Becton Dickinson Acute Care Franklin Lakes, NJ 07417
Z-0027-2016	Zimmer, Inc.	1	Zimmer Universal Locking System, Titanium 3.5mm. Zimmer Implant and Instrument Cases are reusable, non-implantable devices designed to facilitate organization, identification, storage, transportation, cleaning, and sterilization processing of reusable instruments and certain unused implantable devices.

Similar Registrations

Registration Number	Establishment Name	Location
3037591931	DOUBLE WHITE MEDICAL TECHNOLOGY DEVELOPMENT(GUANGZHOU) CO. LTD.	GUANGZHOU Guangdong, CN
3011191212	ESTHETIC ORTHODONTIC COMPANY OF AMERICA LLC	St Petersburg, FL, US
3004146043	GC ASAHI CORPORATION	AICHI, JP
3043149181	HANGZHOU WISE MEDICAL DEVICE CO.,LTD	Hangzhou Zhejiang, CN
3002807315	SYNERGY HEALTH STERILISATION UK LTD	Daventry Northamptonshire, GB

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3023443842. Last updated year: 2026. Please use registration number 3023443842 when referencing this establishment in official correspondence.