Data / Medical devices / China / Huachenyang(shenzhen)technology Co., Ltd
Huachenyang(shenzhen)technology Co., Ltd: FDA-registered device maker in Shenzhen Guangdong, China, 1 510(k) clearance
Huachenyang(shenzhen)technology Co., Ltd is registered with the FDA (registration 3011649813) in Shenzhen Guangdong, China. It lists 7 device types. The FDA files 1 510(k) clearance under its listings, the newest dated August 18, 2022. Registered through 2026. FDA data exported November 3, 2026.
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- FDA registration number
- 3011649813
- Address
- 8, Bldg 4, No.128 Shangnan East Rd., Huangpu Community, XingiaoSt., Bao'an, Shenzhen Guangdong, China, 518125
- Owner or operator
- Huachenyang(Shenzhen)Technology Company Ltd (10048986)
- Roles
- Manufacturer
- First device listed
- March 30, 2015
- Registered through
- 2026
- Brand names listed
- Culture Swab, Stuart medium, Amies medium, Cary Blair medium,, Plastic Tube, Plastic Tube, Swabs with Empty Tube, Dry Swab Tube, Preservation Solution, Sample Collection kit, Saliva Collection kit, Normal Saline, VTM kit,Viral Transport Medium, disposable sampling swab, iClean Viral Transport System (VTM-RT kit),, iClean Viral Transport System(VTM Kit), iClean Viral Transport System(UTM Kit), Viral Transport Media Kit(VTM Kit),
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Applicator, Absorbent Tipped, Sterile | KXG | 1 | Manufacturer | accessdata.fda.gov |
| Container, Specimen Mailer And Storage, Non-Sterile | NNK | 1 | Manufacturer | accessdata.fda.gov |
| Container, Specimen Mailer And Storage, Sterile | KDT | 1 | Manufacturer | accessdata.fda.gov |
| Container, Specimen, Sterile | FMH | 1 | Manufacturer | accessdata.fda.gov |
| Culture Media, Non-Propagating Transport | JSM | 1 | Manufacturer | accessdata.fda.gov |
| Culture Media, Non-Selective And Non-Differential | JSG | 1 | Manufacturer | accessdata.fda.gov |
| General Purpose Reagent | PPM | 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 |
|---|---|---|---|---|---|---|
| August 18, 2022 | K212856 | iClean Viral Transport System (VTM-RT kit) | JSM | Substantially Equivalent | Huachenyang (Shenzhen) Technology Co. , Ltd. | accessdata.fda.gov |
Compare with other makers
- All makers of Container, Specimen Mailer And Storage, Sterile
- All makers of General Purpose Reagent
- All makers of Applicator, Absorbent Tipped, Sterile
- All makers of Container, Specimen, Sterile
- All makers of Culture Media, Non-Selective And Non-Differential
- All makers of Container, Specimen Mailer And Storage, Non-Sterile
Updated August 18, 2022. 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.