Data / Medical devices / China / Juntech (jiaxing) Healthcare Materials Co., Ltd.
Juntech (jiaxing) Healthcare Materials Co., Ltd.: FDA-registered device maker in Nanhu District, Jiaxing Zhejiang, China, 1 510(k) clearance
Juntech (jiaxing) Healthcare Materials Co., Ltd. is registered with the FDA (registration 3009488612) in Nanhu District, Jiaxing Zhejiang, China. It lists 11 device types. The FDA files 1 510(k) clearance under its listings, the newest dated June 4, 2021. Registered through 2026. FDA data exported November 3, 2026.
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- FDA registration number
- 3009488612
- Address
- No 4 Plant, No 1 build of Northeast of Yubei St. and Zhengdong Rd, Yuxin Town, Nanhu District, Jiaxing Zhejiang, China, 314009
- Owner or operator
- Juntech (Jiaxing) Healthcare Materials Co., Ltd. (10038628)
- Roles
- Exporter to the US, Manufacturer
- First device listed
- October 28, 2011
- Registered through
- 2026
- Brand names listed
- DETECTORS AND REMOVERS, GSO Air Mattress, MICROSCOPE SLIDE, Measuring Tape, Mouthpiece, SURGICAL APPAREL, Surgical Face Mask, Surgical Respirator and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Accessory, Surgical Apparel | LYU | 1 | Manufacturer | accessdata.fda.gov |
| Coverslips, Microscope Slide | KES | 1 | Manufacturer | accessdata.fda.gov |
| Detectors And Removers, Lice, (Including Combs) | LJL | 1 | Manufacturer | accessdata.fda.gov |
| Dressing, Wound, Hydrophilic | NAC | 1 | Manufacturer | accessdata.fda.gov |
| Mask, Surgical | FXX | 2 | Manufacturer | accessdata.fda.gov |
| Mattress, Flotation Therapy, Non-Powered | IKY | 1 | Exporter to the US, Manufacturer | accessdata.fda.gov |
| Mouthpiece, Breathing | BYP | 1 | Manufacturer | accessdata.fda.gov |
| Respirator, Surgical | MSH | 2 | Manufacturer | accessdata.fda.gov |
| Slides, Microscope | KEW | 1 | Manufacturer | accessdata.fda.gov |
| Tape And Bandage, Adhesive | KGX | 1 | Manufacturer | accessdata.fda.gov |
| Tape, Measuring, Rulers And Calipers | FTY | 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 |
|---|---|---|---|---|---|---|
| June 4, 2021 | K203704 | Surgical face mask | FXX | Substantially Equivalent | Juntech(Jiaxing)Healthcare Materials Co,.Ltd | accessdata.fda.gov |
Compare with other makers
- All makers of Accessory, Surgical Apparel
- All makers of Dressing, Wound, Hydrophilic
- All makers of Tape, Measuring, Rulers And Calipers
- All makers of Coverslips, Microscope Slide
- All makers of Slides, Microscope
- All makers of Respirator, Surgical
Updated June 4, 2021. 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.