Hitec Medical Co., Ltd.
Registered establishment in Shanghai, China. 17 device types.
Hitec Medical Co., Ltd. is a contract manufacturer holding a current FDA establishment registration. The registration covers Mask, Oxygen, Bougie, Eustachian and 15 other device types. Its earliest product listing with the FDA dates from 2019.
Registration
| Registered name | HITEC MEDICAL CO., LTD |
|---|---|
| Status | Registered |
| Registration expires | 2026 |
| Registration number | 3014208300 |
| FEI number | 3014208300 |
| Establishment type | Contract manufacturer, Manufacturer |
Location
| City | Shanghai |
|---|---|
| Province | Shanghai |
| Address | No. 501, Building 2 Lane 1505, Lian Hang Road, Minhang District |
| Postal code | 201112 |
| Country | China |
What It Makes
| Device type | Class | Listed under the names | Listed since | Chinese makers |
|---|---|---|---|---|
| Airway, Nasopharyngeal | Class 1 | Nasopharyngeal airway | 2020 | 52 |
| Airway, Oropharyngeal, Anesthesiology | Class 1 | Oropharyngeal airway | 2020 | 84 |
| Bottle, Collection, Vacuum | Class 2 | Closed Suction catheter | 2023 | 88 |
| Bougie, Eustachian | Class 1 | Bougie | 2020 | 2 |
| Cannula, Nasal, Oxygen | Class 1 | Nasal oxygen cannula | 2020 | 97 |
| Catheter And Tip, Suction | Class 2 | Connecting tube with yankauer handle | 2020 | 70 |
| Catheters, Suction, Tracheobronchial | Class 1 | Suction catheter | 2020 | 93 |
| Circuit, Breathing (W Connector, Adaptor, Y Piece) | Class 1 | Anesthesia & Breathing circuit | 2020 | 55 |
| Collector, Urine, (And Accessories) For Indwelling Catheter | Class 2 | Urine bag | 2020 | 51 |
| Condenser, Heat And Moisture (Artificial Nose) | Class 1 | Heat and Moisture exchange filter | 2020 | 29 |
| Device, Fixation, Tracheal Tube | Class 1 | Tracheal tube fixer | 2023 | 46 |
| Mask, Gas, Anesthetic | Class 1 | Anesthesia face mask | 2020 | 71 |
| Mask, Oxygen | Class 1 | Oxygen Mask | 2019 | 126 |
| Mask, Oxygen, Low Concentration, Venturi | Class 1 | Multi-vent mask | 2020 | 46 |
| Mask, Oxygen, Non-Rebreathing | Class 1 | Non-rebreath mask | 2020 | 72 |
| Stylet, Tracheal Tube | Class 1 | Intubating stylet | 2020 | 34 |
| Tube, Aspirating, Flexible, Connecting | Class 2 | Suction connecting tube | 2020 | 51 |
From the Company
Published by the company on its own website, not by the FDA.
| Founded | 2011 |
|---|---|
| Factory area | 21,308 m² (5,000 m² clean room) |
| Main products | Respiratory products, Anesthesia products, Urological products, Infusion products, Hospital care solutions |
| Certifications | CE, ISO 13485, MDR CE |
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.