Hantech Medical Device Co., Ltd.
Cixi Zhejiang, CN
HANTECH MEDICAL DEVICE CO., LTD. appears in FDA device records in Cixi Zhejiang, CN. FDA records list 5 510(k) clearances between and , no PMA records and one registered establishment. As of , FDA records show no recalls for this company, and at least one establishment registration is current.
FDA records held for this company
510(k) clearance history
FDA records hold 5 510(k) clearances for Hantech Medical Device Co., Ltd. between 2022 and 2023. The busiest year on record is 2023, with 3. The most recent is 2023, with 3.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 2022 | 2 |
| 2023 | 3 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K231363 | Hantech Pre-filled 0.9% Normal Saline Flush Syringes (Models PFS-1003, PFS-1005, PFS-1010) | NGT | Substantially Equivalent | |
| K222739 | Disposable Insulin Pen Needle | FMI | Substantially Equivalent | |
| K222672 | Disposable Insulin Syringe | FMF | Substantially Equivalent | |
| K221038 | Disposable Medical Masks | FXX | Substantially Equivalent | |
| K220603 | Disposable Medical Safety Hypodermic Needle | FMI | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 3015060216 | 3015060216 | HANTECH MEDICAL DEVICE CO., LTD. | No.288, Sanheng Road, Changhe Industrial Park,Cixi, 315326, Ningbo, P. R. China, Cixi Zhejiang 315326 CN | 2026 | and 8 more, listed in full below |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
- HGEAmniotome
- CBTArterial Blood Sampling Kit
- CATCannula, Nasal, Oxygen
- LJSCatheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days
- NBZClamp And Cutter, Umbilical
- HFWClamp, Umbilical
- SDVClinical Electronic Thermometer
- EKMGutta-Percha
- FXXMask, Surgical
- GAANeedle, Aspiration And Injection, Disposable
- FMINeedle, Hypodermic, Single Lumen
- EKNPoint, Paper, Endodontic
- KMYPositioner, Tooth, Preformed
- EKQPreparer, Root Canal Endodontic
- NGTSaline, Vascular Access Flush
- FPASet, Administration, Intravascular
- FMFSyringe, Piston
- KCQTube Impression And Matrix
Recall records
No recall records for this company in the ingested FDA data.
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain