FDA Registration
Active
🇨🇳 China
NINGBO HANYUE MEDICAL TECHNOLOGY CO.,LTD
Reg #: 3022568093
·
FEI: 3022568093
·
Expires 2026
Products
27
Proprietary Names
29
Establishment Types
3
Classifications
27
Registration Details
- Registration Name
- NINGBO HANYUE MEDICAL TECHNOLOGY CO.,LTD
- Registration Number
- 3022568093
- FEI Number
- 3022568093
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- NO.58 YUGONG ROAD, ERTANG INDUSTRIAL ZONE, ZONGHAN STREET
- City
- CIXI CITY Zhejiang
- Country
- CN
Owner / Operator
- Firm Name
- Ningbo hanyue medical technology CO.,LTD
- Operator Number
- 10084707
- Address
- NO.58 YUGONG ROAD, ERTANG INDUSTRIAL ZONE, ZONGHAN STREET
- City
- CIXI CITY
- State
- Zhejiang
- Postal Code
- 315300
- Country
- CN
- Correspondent
- litao Chen
US Agent
- Business Name
- Regrek LLC
- Contact Name
- Leeyeo Kee
- Address
- 19 Holly Cove Ln.
- City
- Dover
- State
- DE
- ZIP
- 19901
- Country
- US
- [email protected]
- Phone
- 302 6089028
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Cup, Menstrual | HHE | Class 2 | Obstetrics/Gynecology | No | 2024-06-13 |
| Airway, Nasopharyngeal | BTQ | Class 1 | Anesthesiology | No | 2022-03-24 |
| Cannula, Nasal, Oxygen | CAT | Class 1 | Anesthesiology | No | 2022-03-24 |
| Apparatus, Suction, Operating-Room, Wall Vacuum Powered | GCX | Class 2 | General Hospital | No | 2024-06-13 |
| Tourniquet, Nonpneumatic | GAX | Class 1 | General, Plastic Surgery | No | 2022-03-24 |
| Nebulizer, Medicinal, Non-Ventilatory (Atomizer) | CCQ | Class 1 | Anesthesiology | No | 2022-03-24 |
| Vibrator For Therapeutic Use, Genital | KXQ | Class 2 | Obstetrics/Gynecology | No | 2024-06-13 |
| Mask, Oxygen, Non-Rebreathing | KGB | Class 1 | Anesthesiology | No | 2022-03-24 |
| Condenser, Heat And Moisture (Artificial Nose) | BYD | Class 1 | Anesthesiology | No | 2022-03-24 |
| Device, Heimlich Maneuver Assist | MZT | Class 2 | Anesthesiology | No | 2025-05-15 |
| First Aid Kit Without Drug | OHO | Class 1 | General, Plastic Surgery | No | 2024-06-13 |
| Humidifier, Non-Direct Patient Interface (Home-Use) | KFZ | Class 1 | Anesthesiology | No | 2022-03-24 |
| Dressing, Wound, Occlusive | NAD | Class 1 | General, Plastic Surgery | No | 2025-09-09 |
| Cover, Cast | KIA | Class 1 | General Hospital | No | 2023-06-01 |
| Exerciser, Measuring | ISD | Class 2 | Physical Medicine | No | 2024-09-13 |
| Clip, Removable (Skin) | FZQ | Class 1 | General, Plastic Surgery | No | 2025-09-09 |
| Pump, Nebulizer, Electrically Powered | JPW | Class 1 | Ear, Nose, Throat | No | 2025-02-27 |
| Electrode, Electrocardiograph | DRX | Class 2 | Cardiovascular | No | 2025-07-18 |
| Mask, Oxygen, Low Concentration, Venturi | BYF | Class 1 | Anesthesiology | No | 2022-03-24 |
| First Aid Kit With Drug | LRR | Class N | Unknown | No | 2024-06-13 |
| Mask, Gas, Anesthetic | BSJ | Class 1 | Anesthesiology | No | 2022-03-24 |
| Catheters, Suction, Tracheobronchial | BSY | Class 1 | Anesthesiology | No | 2024-06-13 |
| Airway, Oropharyngeal, Anesthesiology | CAE | Class 1 | Anesthesiology | No | 2022-03-24 |
| Exerciser, Non-Measuring | ION | Class 1 | Physical Medicine | No | 2024-09-13 |
| Enteral Administration Kit (Adult & Pediatric) | PRM | Class 2 | Gastroenterology, Urology | No | 2022-03-24 |
| Cannula, Surgical, General & Plastic Surgery | GEA | Class 1 | General, Plastic Surgery | No | 2022-03-24 |
| Mouthpiece, Breathing | BYP | Class 1 | Anesthesiology | No | 2022-03-24 |
Proprietary Names
Menstrual Cup
Nasopharyngeal Airway
Nasal Oxygen Cannulas
Choking Rescue Device
Combat application Tourniquets
Nebulize Mask
Kegel Ball
CPR Mask; Non-Breathing Oxygen Mask
Heat Moisture Exchange Filter
Choking Rescue Device, Choke Reliever
First Aid Kit Without Drug
Hunidifier Chamber
Foam Dressing, Hydrocolloid Dressing, Hydrocolloid Foam Dressina, Silicone Dressing, NPWT Dressing,
Nonwoven wound dressind, Super Absorbency Dressing, Transparent Dressing, CovaWound (Confidential),
MedNac (Confidential)
Waterproof Cast Protector
Breathing Exerciser
Wound Closure Device
Pump, Nebulizer, Electrically Powered
ECG Electrodes
CPAP mask; Continuous Positive Airway Pressure Mask; Non-lnvasive Ventilation Mask
First Aid Kit With Drug
Anesthesia Mask
Laryngeal Mask Airways; Oropharyngeal Airway; Laryngeal Mask
Breathing Trainer
Stomach Tube (Gastric Calibration Tube)
CPAP Tube; Disposable Breathing Circuits
Silicone/SEBS/PVC Manual Resuscitators (Reservoir)
Silicone/SEBS/PVC Manual Resuscitators (Mask); Silicone/SEBS/PVC Manual Resuscitators (Oxygen Tube);
Establishment Types
Export Device to the United States But Perform No Other Operation on Device
Manufacture Medical Device for Another Party (Contract Manufacturer)
Manufacture Medical Device