Zhejiang Jinhua Huatong Medical Appliance Co., Ltd.
Registered establishment in Jinhua, Zhejiang, China. 4 device types.
Zhejiang Jinhua Huatong Medical Appliance Co., Ltd. is a manufacturer holding a current FDA establishment registration. The registration covers Shield, Nipple, Electrophoretic Method, Catecholamines and 2 other device types. Its earliest product listing with the FDA dates from 2011.
Registration
| Registered name | ZHEJIANG JINHUA HUATONG MEDICAL APPLIANCE CO., LTD. |
|---|---|
| Status | Registered |
| Registration expires | 2026 |
| Registration number | 3010361165 |
| FEI number | 3010361165 |
| Establishment type | Manufacturer |
Chinese Registration
| Chinese legal name | 浙江省金华市华通医疗器械有限公司 |
|---|---|
| Unified social credit code | 913307012563953251 |
| Source | export sales certificate, Zhejiang medical products administration |
Location
| City | Jinhua |
|---|---|
| Province | Zhejiang |
| Address | Unit 1-2, Building 4, No. 168 Kechang Street |
| Postal code | 321016 |
| Country | China |
What It Makes
| Device type | Class | Listed under the names | Listed since | Chinese makers |
|---|---|---|---|---|
| Electrocautery, Gynecologic (And Accessories) | Class 2 | Disposable Electrosurgical Active Electrodes (Electrosurgical Pencils) | 2021 | 6 |
| Electrophoretic Method, Catecholamines | Class 1 | Nipple Protector, Disposable Electrosurgical Active Electrodes (Electrosurgical Pencils) | 2013 | 1 |
| Electrosurgical, Cutting & Coagulation & Accessories | Class 2 | Disposable Electrosurgical Active Electrodes (Electrosurgical Pencils), Disposable Neutral Electrodes | 2013 | 65 |
| Shield, Nipple | Class 1 | Nipple Protector, Disposable Electrosurgical Active Electrodes (Electrosurgical Pencils) | 2011 | 15 |
Clearances
No clearance names Zhejiang Jinhua Huatong Medical Appliance Co., Ltd. as applicant. 4 are held by other companies and named on this establishment’s own product listings: the device is cleared under that company’s 510(k) and listed under this registration.
| Clearance | Decision date | Product code | Route | Held by |
|---|---|---|---|---|
| K132199 | 2013-10-03 | GEI | Traditional | Deroyal Industries, Inc. |
| K002042 | 2001-02-01 | HGI | Traditional | New England Medical, Inc. |
| K931982 | 1993-10-05 | GEI | Traditional | New England Medical, Inc. |
| K823670 | 1983-01-12 | GEI | Traditional | Surgicare Scientific Laboratory, Inc. |
From the Company
Published by the company on its own website, not by the FDA.
| Founded | 1994 |
|---|---|
| Main products | Electrosurgical pencils, Patient plates, CPM devices, Disposable surgical electrodes |
| Certifications | CE, ISO 9001, ISO 13485 |
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.