FDA Registration
Active
🇨🇳 China
HANTECH MEDICAL DEVICE CO., LTD.
Reg #: 3015060216
·
FEI: 3015060216
·
Expires 2026
Products
18
Proprietary Names
23
Establishment Types
2
Classifications
18
Registration Details
- Registration Name
- HANTECH MEDICAL DEVICE CO., LTD.
- Registration Number
- 3015060216
- FEI Number
- 3015060216
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- No.288, Sanheng Road, Changhe Industrial Park,Cixi, 315326, Ningbo, P. R. China
- City
- Cixi Zhejiang
- Country
- CN
Regulatory Submissions
- 510(k) Number
- K221038
Owner / Operator
- Firm Name
- Hantech Medical Device Co., Ltd.
- Operator Number
- 10058745
- Address
- No.288, Sanheng Road, Changhe Industrial Park,Cixi, 315326, Ningbo, P. R. China
- City
- Cixi
- State
- Zhejiang
- Postal Code
- 315326
- Country
- CN
- Correspondent
- Rachel Jin
US Agent
- Business Name
- ABMED MEDICAL TECHNOLOGY INC
- Contact Name
- hui hong
- Address
- 800 East Wishkah Street, 1021 Aberdeen,
- City
- Aberdeen
- State
- WA
- ZIP
- 98520
- Country
- US
- [email protected]
- Phone
- 303 8000162
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Cannula, Nasal, Oxygen | CAT | Class 1 | Anesthesiology | No | 2021-03-07 |
| Amniotome | HGE | Class 1 | Obstetrics/Gynecology | No | 2022-06-09 |
| Mask, Surgical | FXX | Class 2 | General, Plastic Surgery | No | 2022-09-07 |
| Saline, Vascular Access Flush | NGT | Class 2 | General Hospital | No | 2023-10-19 |
| Preparer, Root Canal Endodontic | EKQ | Class 1 | Dental | No | 2022-09-22 |
| Needle, Hypodermic, Single Lumen | FMI | Class 2 | General Hospital | No | 2023-04-20 |
| Syringe, Piston | FMF | Class 2 | General Hospital | No | 2023-03-12 |
| Clamp, Umbilical | HFW | Class 2 | Obstetrics/Gynecology | No | 2022-06-09 |
| Clinical Electronic Thermometer | SDV | Class 2 | General Hospital | No | 2026-01-28 |
| Tube Impression And Matrix | KCQ | Class 1 | Dental | No | 2023-06-15 |
| Arterial Blood Sampling Kit | CBT | Class 1 | Anesthesiology | No | 2025-05-11 |
| Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days | LJS | Class 2 | General Hospital | No | 2024-09-30 |
| Set, Administration, Intravascular | FPA | Class 2 | General Hospital | No | 2022-01-10 |
| Clamp And Cutter, Umbilical | NBZ | Class 2 | Obstetrics/Gynecology | No | 2022-06-09 |
| Needle, Aspiration And Injection, Disposable | GAA | Class 1 | General, Plastic Surgery | No | 2022-04-01 |
| Positioner, Tooth, Preformed | KMY | Class 1 | Dental | No | 2022-06-22 |
| Gutta-Percha | EKM | Class 1 | Dental | No | 2020-08-03 |
| Point, Paper, Endodontic | EKN | Class 1 | Dental | No | 2023-04-11 |
Proprietary Names
Precision Sampling Set
Amniotic Membrane Perforators
Disposable Medical Masks
KenFlush KFS1000
PRE-FILLED SALINE FLUSH SYRINGE,10ML , ITEM 5079
PRE-FILLED SALINE FLUSH SYRINGE,5ML , ITEM 5078
Pre-filled 0.9% Normal Saline Flush Syringes (Models PFS-1003, PFS- 1005, PFS-1010)
EndoActivator Tips
Disposable Insulin Pen Needle
Disposable Insulin Syringe
Umbilical Cord Clamp
Braun ThermoScan Lens Filters
Disposable Medical Safety Hypodermic Needle
Mixing Tips
Arterial Blood Gas Samplers
Safety Arterial Blood Gas Samplers
Extension set (T-fitting) RM0752504
Umbilical cord clamp clipper
filter straw
Dental Foil
Mouthguard
Gutta Purcha Points
Absorbent Paper Points
Establishment Types
Manufacture Medical Device
Manufacture Medical Device for Another Party (Contract Manufacturer)