Data / Medical devices / China / Zhejiang Jinhua Huatong Medical Appliance Co., Ltd.
Zhejiang Jinhua Huatong Medical Appliance Co., Ltd.: FDA-registered device maker in Jinhua Zhejiang, China, 4 510(k) clearances
Zhejiang Jinhua Huatong Medical Appliance Co., Ltd. is registered with the FDA (registration 3010361165) in Jinhua Zhejiang, China. It lists 4 device types. The FDA files 4 510(k) clearances under its listings, the newest dated October 3, 2013. Registered through 2026. FDA data exported November 3, 2026.
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- FDA registration number
- 3010361165
- Address
- Unit 1-2, Building 4, No. 168 Kechang Street Qiubin Street,Wucheng District, Jinhua Zhejiang, China, 321016
- Owner or operator
- Zhejiang Jinhua Huatong Medical Appliance Co., Ltd. (10044444)
- Roles
- Manufacturer
- First device listed
- July 26, 2011
- Registered through
- 2026
- Brand names listed
- Disposable Electrosurgical Active Electrodes (Electrosurgical Pencils), Disposable Neutral Electrodes, Nipple Protector
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Electrocautery, Gynecologic (And Accessories) | HGI | 2 | Manufacturer | accessdata.fda.gov |
| Electrophoretic Method, Catecholamines | CHT | 1 | Manufacturer | accessdata.fda.gov |
| Electrosurgical, Cutting & Coagulation & Accessories | GEI | 2 | Manufacturer | accessdata.fda.gov |
| Shield, Nipple | HFS | 1 | Manufacturer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| October 3, 2013 | K132199 | DEROYAL ELECTROSURGICAL PENCIL, ROCKER STYLE WITHOUT HOLSTER, DEROYAL ELECTROSURGICAL PENCIL, BUTTON STYLE WITHOUT HOLST | GEI | Substantially Equivalent | Deroyal Industries, Inc. | accessdata.fda.gov |
| February 1, 2001 | K002042 | TRUCONE ROTATIONAL CONE BIOPSY INSTRUMENT, MODEL 231812 - 233018 | HGI | Substantially Equivalent | New England Medical Corp. | accessdata.fda.gov |
| October 5, 1993 | K931982 | NEW ENGLAND MEDICAL GROUNDING PAD | GEI | Substantially Equivalent | New England Medical, Inc. | accessdata.fda.gov |
| January 12, 1983 | K823670 | E.S. PENCIL | GEI | Substantially Equivalent | Surgicare Scientific Laboratory, Inc. | accessdata.fda.gov |
Compare with other makers
- All makers of Electrosurgical, Cutting & Coagulation & Accessories
- All makers of Shield, Nipple
- All makers of Electrocautery, Gynecologic (And Accessories)
Updated October 3, 2013. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.