FDA Registration
Active
🇨🇳 China
NINGBO HUAKUN MEDICAL EQUIPMENT CO.,LTD
Reg #: 3009747810
·
FEI: 3009747810
·
Expires 2026
Products
19
Proprietary Names
20
Establishment Types
2
Classifications
19
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Registration Details
- Registration Name
- NINGBO HUAKUN MEDICAL EQUIPMENT CO.,LTD
- Registration Number
- 3009747810
- FEI Number
- 3009747810
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- NO.208 Binjiang Road, Cixi High-tech Industrial Development Zone
- City
- Cixi Zhejiang
- Country
- CN
Regulatory Submissions
- 510(k) Number
- K221472
Owner / Operator
- Firm Name
- Ningbo Huakun Medical Equipment Co.,ltd
- Operator Number
- 10041496
- Address
- NO.208, Binjiang Road, Cixi High-tech Industrial Development Zone
- City
- Cixi
- State
- Zhejiang
- Postal Code
- 315301
- Country
- CN
- Correspondent
- Lei Xi
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Tubing, Pressure And Accessories | BYX | Class 1 | Anesthesiology | No | 2023-11-03 |
| Cutter, Surgical | FZT | Class 1 | General, Plastic Surgery | No | 2024-11-14 |
| Shield, Eye, Ophthalmic (Including Sunlamp Protective Eyewear And Post-Mydriatic Eyewear) | HOY | Class 1 | Ophthalmic | No | 2020-04-16 |
| Airway, Oropharyngeal, Anesthesiology | CAE | Class 1 | Anesthesiology | No | 2021-11-29 |
| Device, Fixation, Tracheal Tube | CBH | Class 1 | Anesthesiology | No | 2012-07-31 |
| Condenser, Heat And Moisture (Artificial Nose) | BYD | Class 1 | Anesthesiology | No | 2014-03-26 |
| Hemostatic Metal Clip For The Gi Tract | PKL | Class 2 | Gastroenterology, Urology | No | 2024-09-04 |
| Catheters, Suction, Tracheobronchial | BSY | Class 1 | Anesthesiology | No | 2012-07-31 |
| Mask, Oxygen | BYG | Class 1 | Anesthesiology | No | 2012-07-31 |
| Support, Breathing Tube | JAY | Class 1 | Anesthesiology | No | 2012-07-31 |
| Laryngoscope, Rigid | CCW | Class 1 | Anesthesiology | No | 2013-09-12 |
| Instrument, Ultrasonic Surgical | LFL | Class U | Unknown | No | 2025-02-09 |
| Anesthesia Breathing Circuit Kit (Adult & Pediatric) | OFP | Class 1 | Anesthesiology | No | 2019-02-21 |
| Bag, Reservoir | BTC | Class 1 | Anesthesiology | No | 2012-07-31 |
| Filter, Bacterial, Breathing-Circuit | CAH | Class 2 | Anesthesiology | No | 2023-03-08 |
| Accessories, Catheter | KGZ | Class 1 | General, Plastic Surgery | No | 2023-05-18 |
| Bottle, Collection, Vacuum | KDQ | Class 2 | General Hospital | No | 2023-05-18 |
| Mask, Gas, Anesthetic | BSJ | Class 1 | Anesthesiology | No | 2012-07-31 |
| Endoscopic Injection Needle, Gastroenterology-Urology | FBK | Class 2 | Gastroenterology, Urology | No | 2024-09-04 |
Proprietary Names
TUBING, PRESSURE AND ACCESSORIES-CPAP Tubing
Catheter trimmer
Shield, eye, ophthalmic (including sunlamp protective eyewear and post-mydriatic eyewear)
AIRWAY, OROPHARYNGEAL, ANESTHESIOLOGY
DEVICE, FIXATION, TRACHEAL TUBE
CONDENSER, HEAT AND MOISTURE (ARTIFICIAL NOSE)
Disposable Hemostatic Clips
CATHETERS, SUCTION, TRACHEOBRONCHIAL
MASK, OXYGEN, NON-REBREATHING
SUPPORT, BREATHING TUBE
LARYNGOSCOPE, NON-RIGID
laryngoscope, rigid--video laryngoscope
Ultrasonic Scalpel
Anesthesia Breathing Circuit Kit (Adult & Pediatric)
BAG, RESERVOIR
Filter, bacterial, breathing-circuit
General & Plastic Surgery Accessories, Catheter
Bottle, Collection, Vacuum
MASK, OXYGEN
Disposable Injection Needles
Establishment Types
Manufacture Medical Device
Sterilize Medical Device for Another Party (Contract Sterilizer)