FDA Registration
Active
🇨🇳 China
HITEC MEDICAL CO., LTD
Reg #: 3014208300
·
FEI: 3014208300
·
Expires 2026
Products
17
Proprietary Names
17
Establishment Types
2
Classifications
17
Registration Details
- Registration Name
- HITEC MEDICAL CO., LTD
- Registration Number
- 3014208300
- FEI Number
- 3014208300
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- No. 501, Building 2 Lane 1505, Lian Hang Road, Minhang District
- City
- Shanghai
- Country
- CN
Owner / Operator
- Firm Name
- Hitec Medical Co., Ltd
- Operator Number
- 10062211
- Address
- No. 501, Building 2 Lane 1505, Lian Hang Road, Minhang District
- City
- Shanghai
- State
- CN-SH
- Postal Code
- 201112
- Country
- CN
- Correspondent
- Jackie Sheng
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Mask, Oxygen, Low Concentration, Venturi | BYF | Class 1 | Anesthesiology | No | 2020-01-15 |
| Collector, Urine, (And Accessories) For Indwelling Catheter | KNX | Class 2 | Gastroenterology, Urology | No | 2020-01-15 |
| Mask, Oxygen, Non-Rebreathing | KGB | Class 1 | Anesthesiology | No | 2020-01-15 |
| Airway, Oropharyngeal, Anesthesiology | CAE | Class 1 | Anesthesiology | No | 2020-01-15 |
| Bougie, Eustachian | KBI | Class 1 | Ear, Nose, Throat | No | 2020-01-15 |
| Airway, Nasopharyngeal | BTQ | Class 1 | Anesthesiology | No | 2020-01-15 |
| Circuit, Breathing (W Connector, Adaptor, Y Piece) | CAI | Class 1 | Anesthesiology | No | 2020-01-15 |
| Catheters, Suction, Tracheobronchial | BSY | Class 1 | Anesthesiology | No | 2020-01-15 |
| Catheter And Tip, Suction | JOL | Class 2 | General Hospital | No | 2020-01-15 |
| Tube, Aspirating, Flexible, Connecting | BYY | Class 2 | General Hospital | No | 2020-01-15 |
| Device, Fixation, Tracheal Tube | CBH | Class 1 | Anesthesiology | No | 2023-11-27 |
| Stylet, Tracheal Tube | BSR | Class 1 | Anesthesiology | No | 2020-01-15 |
| Bottle, Collection, Vacuum | KDQ | Class 2 | General Hospital | No | 2023-08-24 |
| Cannula, Nasal, Oxygen | CAT | Class 1 | Anesthesiology | No | 2020-01-15 |
| Mask, Gas, Anesthetic | BSJ | Class 1 | Anesthesiology | No | 2020-01-15 |
| Mask, Oxygen | BYG | Class 1 | Anesthesiology | No | 2019-12-30 |
| Condenser, Heat And Moisture (Artificial Nose) | BYD | Class 1 | Anesthesiology | No | 2020-01-20 |
Proprietary Names
Multi-vent mask
Urine bag
Non-rebreath mask
Oropharyngeal airway
Bougie
Nasopharyngeal airway
Anesthesia & Breathing circuit
Suction catheter
Connecting tube with yankauer handle
Suction connecting tube
Tracheal tube fixer
Intubating stylet
Closed Suction catheter
Nasal oxygen cannula
Anesthesia face mask
Oxygen Mask
Heat and Moisture exchange filter
Establishment Types
Manufacture Medical Device for Another Party (Contract Manufacturer)
Manufacture Medical Device