Hantech Medical Device Co., Ltd.
Registered establishment in Cixi, Zhejiang, China. 18 device types, 5 clearances.
Hantech Medical Device Co., Ltd. is a contract manufacturer holding a current FDA establishment registration. The registration covers Amniotome, Gutta-Percha and 16 other device types. Its earliest product listing with the FDA dates from 2020.
18device types registered with the FDA
5510(k) clearances
Registration
| Registered name | HANTECH MEDICAL DEVICE CO., LTD. |
|---|---|
| Status | Registered |
| Registration expires | 2026 |
| Registration number | 3015060216 |
| FEI number | 3015060216 |
| Establishment type | Contract manufacturer, Manufacturer |
Chinese Registration
| Chinese legal name | 1、宁波汉科医疗器械有限公司 2、汉科（宁波）医疗科技有限公司 |
|---|---|
| Source | provincial manufacturer licence lists |
Location
| City | Cixi |
|---|---|
| Province | Zhejiang |
| Address | No.288, Sanheng Road, Changhe Industrial Park,Cixi, 315326, Ningbo, P. R. China |
| Postal code | 315326 |
| Country | China |
What It Makes
| Device type | Class | Listed under the names | Listed since | Chinese makers |
|---|---|---|---|---|
| Amniotome | Class 1 | Amniotic Membrane Perforators | 2022 | 5 |
| Arterial Blood Sampling Kit | Class 1 | Safety Arterial Blood Gas Samplers, Arterial Blood Gas Samplers | 2025 | 1 |
| Cannula, Nasal, Oxygen | Class 1 | Precision Sampling Set | 2021 | 97 |
| Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days | Class 2 | Extension set (T-fitting) RM0752504 | 2024 | 5 |
| Clamp And Cutter, Umbilical | Class 2 | Umbilical cord clamp clipper | 2022 | 4 |
| Clamp, Umbilical | Class 2 | Umbilical Cord Clamp | 2022 | 14 |
| Clinical Electronic Thermometer | Class 2 | Braun ThermoScan Lens Filters | 2026 | 49 |
| Gutta-Percha | Class 1 | Gutta Purcha Points | 2020 | 42 |
| Mask, Surgical | Class 2 | Disposable Medical Masks | 2022 | 125 |
| Needle, Aspiration And Injection, Disposable | Class 1 | filter straw | 2022 | 37 |
| Needle, Hypodermic, Single Lumen | Class 2 | Disposable Medical Safety Hypodermic Needle, Disposable Insulin Pen Needle | 2022 | 71 |
| Point, Paper, Endodontic | Class 1 | Absorbent Paper Points | 2023 | 35 |
| Positioner, Tooth, Preformed | Class 1 | Dental Foil, Mouthguard | 2022 | 19 |
| Preparer, Root Canal Endodontic | Class 1 | EndoActivator Tips | 2022 | 8 |
| Saline, Vascular Access Flush | Class 2 | One-Care Saline Flush Syringe, Sterile Fluid Path 10ml, KenFlush KFS1000, PRE-Filled Saline Flush SYRINGE,5ML, Item 5078, PRE-Filled Saline Flush SYRINGE,10ML, Item 5079, One-Care Saline Flush Syringe, Sterile Fluid Path 5ml | 2023 | 10 |
| Set, Administration, Intravascular | Class 2 | 2022 | 49 | |
| Syringe, Piston | Class 2 | Disposable Insulin Syringe | 2023 | 60 |
| Tube Impression And Matrix | Class 1 | Mixing Tips | 2023 | 7 |
Clearances
| Clearance | Decision date | Product code | Route | Held by |
|---|---|---|---|---|
| K231363 | 2023-09-27 | NGT | Traditional | This company |
| K222739 | 2023-04-06 | FMI | Traditional | This company |
| K222672 | 2023-03-06 | FMF | Traditional | This company |
| K221038 | 2022-09-01 | FXX | Traditional | This company |
| K220603 | 2022-08-23 | FMI | Traditional | This company |
From the Company
Published by the company on its own website, not by the FDA.
| Founded | 2004 |
|---|---|
| Employees | 201-500 |
| Main products | IV sets, Safety needles, Disposable syringes, Insulin pens, Vascular intervention products, Face masks |
| Certifications | ISO13485, ISO9001, ISO14001, ISO45001, FDA, CE, NMPA, MFDS |
| Export markets | United States, Singapore, global markets |
| OEM and ODM | Offered |
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.