Henan Baistra Medical Devices Limited

Registered establishment in Zhengzhou, Henan, China. 34 device types.

Registry build 21.09.26

Henan Baistra Medical Devices Limited is a manufacturer holding a current FDA establishment registration. The registration covers Bur, Dental, Gutta-Percha and 32 other device types. Its earliest product listing with the FDA dates from 2022.

Registration

FDA registration record for Henan Baistra Medical Devices Limited
Registered name HENAN BAISTRA MEDICAL DEVICES LIMITED
Status Registered
Registration expires 2026
Registration number 3023443842
FEI number 3023443842
Establishment type Manufacturer, Exporter

Location

Address of Henan Baistra Medical Devices Limited
City Zhengzhou
Province Henan
Address 80 DIANCHANG RD, BUILDING 162, FLOOR 20, SUITE 61, HI-TECH INDUSTRIES DEVELOPMENT,
Postal code 450000
Country China

What It Makes

Device types Henan Baistra Medical Devices Limited is registered to make
Device type Class Listed under the names Listed since Chinese makers
Accessories, Implant, Dental, Endosseous Class 1 Dental Implant Torque Wrench 2025 70
Accessories, Retractor, Dental Class 1 Accessories, Retractor, Dental 2022 37
Agent, Polishing, Abrasive, Oral Cavity Class 1 Agent, Polishing, Abrasive, Oral Cavity 2026 25
Band, Elastic, Orthodontic Class 1 Band, Elastic, Orthodontic 2022 36
Blade, Scalpel Class 1 Blade, Scalpel 2026 41
Bracket, Metal, Orthodontic Class 1 Bracket, Metal, Orthodontic 2022 52
Bur, Dental Class 1 BUR, Dental 2022 46
Cart, Emergency, Cardiopulmonary (Excluding Equipment) Class 1 Dental Trolley Cart 2025 34
Chair, Adjustable, Mechanical Class 1 Chair, Adjustable, Mechanical 2022 46
Chair, Examination And Treatment Class 1 Barrier Covers, Barrier Film 2025 23
Clamp, Wire, Orthodontic Class 1 Clamp, Wire, Orthodontic 2022 27
Dispenser, Solid Medication Class 1 Dispenser, solid medication 2026 68
File, Pulp Canal, Endodontic Class 1 File, Pulp Canal, Endodontic 2022 53
Gutta-Percha Class 1 Gutta-Percha 2022 42
Instrument, Filling, Plastic, Dental Class 1 Instrument, Filling, Plastic, Dental 2022 23
Instrument, Manual, Surgical, General Use Class 1 Instrument, Manual, Surgical, General USE 2026 110
Instruments, Dental Hand Class 1 Instruments, Dental Hand 2025 64
Light, Operating, Dental Class 1 Dental Operating Light 2025 16
Loupe, Binocular, Low Power Class 1 Loupe, binocular, low power 2022 13
Mirror, Mouth Class 1 Mirror, Mouth 2026 94
Mouthpiece, Saliva Ejector Class 1 Mouthpiece, saliva ejector 2025 68
Orthopedic Manual Surgical Instrument Class 1 Orthopedic manual surgical instrument 2022 53
Paper, Articulation Class 1 Paper, Articulation 2026 12
Patient Personal Hygiene Kit Class 1 Patient personal hygiene kit 2022 16
Point, Abrasive Class 1 Point, Abrasive 2025 9
Strip, Polishing Agent Class 1 Polishing Strip 2025 18
Syringe, Restorative And Impression Material Class 1 Syringe, Restorative AND Impression Materia 2025 49
Tray, Fluoride, Disposable Class 1 Tray, Fluoride, Disposable 2025 22
Tray, Impression, Preformed Class 1 Tray, Impression, Preformed 2025 73
Tray, Surgical, Instrument Class 1 Tray, Surgical, Instrument 2025 105
Tube, Orthodontic Class 1 Tube, Orthodontic 2022 34
Unit, Operative Dental, Accessories Class 1 Unit, operative dental, accessories 2025 65
Wax, Dental, Intraoral Class 1 WAX, Dental, Intraoral 2026 55
Wheel, Polishing Agent Class 1 Wheel, Polishing Agent 2025 15

From the Company

Published by the company on its own website, not by the FDA.

Information published by Henan Baistra Medical Devices Limited
Founded 2008
Employees 100+
Factory area 4000 m² (GMP purification workshop)
Main products Disposable dental products, Orthodontic products, Dental disinfection products
Certifications ISO 13485, ISO 9001, FDA
Export markets United States, Mexico, Europe, Brazil, Turkey, Middle East, Southeast Asia
OEM and ODM Offered

Nearby Manufacturers

Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.

The manufacturer named here can complete this record.

Where China Actually Supplies

Every device page names the company that lists it and the factories registered to make the same thing. These are the sections with the most of them.

5,100manufacturers registered in China
2,581device types they are registered for
340,248device records, each naming its maker
31provinces with a registered manufacturer