FDA Registration
Active
🇨🇳 China
HENAN BAISTRA MEDICAL DEVICES LIMITED
Reg #: 3023443842
·
FEI: 3023443842
·
Expires 2026
Products
33
Proprietary Names
34
Establishment Types
2
Classifications
33
Registration Details
- Registration Name
- HENAN BAISTRA MEDICAL DEVICES LIMITED
- Registration Number
- 3023443842
- FEI Number
- 3023443842
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- 80 DIANCHANG RD, BUILDING 162, FLOOR 20, SUITE 61, HI-TECH INDUSTRIES DEVELOPMENT,
- City
- Zhengzhou Henan
- Country
- CN
Owner / Operator
- Firm Name
- HENAN BAISTRA MEDICAL DEVICES LIMITED
- Operator Number
- 10085746
- Address
- 80 DIANCHANG RD, BUILDING 162, FLOOR 20, SUITE 61, HI-TECH INDUSTRIES DEVELOPMENT,
- City
- Zhengzhou
- State
- Henan
- Postal Code
- 450000
- Country
- CN
- Correspondent
- Ya Li
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Strip, Polishing Agent | EHM | Class 1 | Dental | No | 2025-02-07 |
| Light, Operating, Dental | EAZ | Class 1 | Dental | No | 2025-02-21 |
| Dispenser, Solid Medication | NXB | Class 1 | Physical Medicine | No | 2026-04-26 |
| Bracket, Metal, Orthodontic | EJF | Class 1 | Dental | No | 2022-07-28 |
| Blade, Scalpel | GES | Class 1 | General, Plastic Surgery | No | 2026-04-22 |
| Mirror, Mouth | EAX | Class 1 | Dental | No | 2026-04-13 |
| Instrument, Filling, Plastic, Dental | EIY | Class 1 | Dental | No | 2022-07-28 |
| Mouthpiece, Saliva Ejector | DYN | Class 1 | Dental | No | 2025-12-19 |
| Instruments, Dental Hand | DZN | Class 1 | Dental | No | 2025-12-19 |
| Wheel, Polishing Agent | EJQ | Class 1 | Dental | No | 2025-12-19 |
| Wax, Dental, Intraoral | EGD | Class 1 | Dental | No | 2026-04-22 |
| Gutta-Percha | EKM | Class 1 | Dental | No | 2022-07-28 |
| Tube, Orthodontic | DZD | Class 1 | Dental | No | 2022-07-28 |
| Paper, Articulation | EFH | Class 1 | Dental | No | 2026-04-22 |
| Syringe, Restorative And Impression Material | EID | Class 1 | Dental | No | 2025-12-19 |
| Chair, Examination And Treatment | FRK | Class 1 | General Hospital | No | 2025-06-18 |
| Chair, Adjustable, Mechanical | INN | Class 1 | Physical Medicine | No | 2022-07-28 |
| Clamp, Wire, Orthodontic | ECN | Class 1 | Dental | No | 2022-07-28 |
| Cart, Emergency, Cardiopulmonary (Excluding Equipment) | BZN | Class 1 | Anesthesiology | No | 2025-01-12 |
| File, Pulp Canal, Endodontic | EKS | Class 1 | Dental | No | 2022-07-28 |
| Tray, Surgical, Instrument | FSM | Class 1 | General, Plastic Surgery | No | 2025-12-19 |
| Accessories, Retractor, Dental | EIF | Class 1 | Dental | No | 2022-07-28 |
| Bur, Dental | EJL | Class 1 | Dental | No | 2022-07-28 |
| Patient Personal Hygiene Kit | NSB | Class 1 | Dental | No | 2022-07-28 |
| Point, Abrasive | EHL | Class 1 | Dental | No | 2025-12-18 |
| Band, Elastic, Orthodontic | ECI | Class 1 | Dental | No | 2022-07-28 |
| Unit, Operative Dental, Accessories | NRD | Class 1 | Dental | No | 2025-12-20 |
| Orthopedic Manual Surgical Instrument | LXH | Class 1 | Orthopedic | No | 2022-07-28 |
| Loupe, Binocular, Low Power | HJH | Class 1 | Ophthalmic | No | 2022-07-28 |
| Tray, Impression, Preformed | EHY | Class 1 | Dental | No | 2025-12-19 |
| Accessories, Implant, Dental, Endosseous | NDP | Class 1 | Dental | No | 2025-07-29 |
| Agent, Polishing, Abrasive, Oral Cavity | EJR | Class 1 | Dental | No | 2026-04-22 |
| Tray, Fluoride, Disposable | KMT | Class 1 | Dental | No | 2025-12-19 |
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
Patient personal hygiene kit
POINT, ABRASIVE
BAND, ELASTIC, ORTHODONTIC
Unit, operative dental, accessories
Orthopedic manual surgical instrument
Loupe, binocular, low power
TRAY, IMPRESSION, PREFORMED
Dental Implant Torque Wrench
AGENT, POLISHING, ABRASIVE, ORAL CAVITY
TRAY, FLUORIDE, DISPOSABLE
Establishment Types
Export Device to the United States But Perform No Other Operation on Device
Manufacture Medical Device