Huachenyang(Shenzhen)Technology Co., Ltd.
Manufacturer and brand owner in Shenzhen, Guangdong, China. 7 device types, 8 products catalogued, 1 clearance.
Huachenyang(Shenzhen)Technology Co., Ltd. is a manufacturer holding a current FDA establishment registration. The registration covers General Purpose Reagent, Container, Specimen, Sterile and 5 other device types. 6 of its products are catalogued under its own name. Its earliest product listing with the FDA dates from 2015.
Registration
| Registered name | HUACHENYANG(SHENZHEN)TECHNOLOGY CO., LTD |
|---|---|
| Status | Registered |
| Registration expires | 2026 |
| Registration number | 3011649813 |
| FEI number | 3011649813 |
| DUNS | 548237157 |
| Establishment type | Manufacturer |
Chinese Registration
| Chinese legal name | 深圳市华晨阳科技有限公司 |
|---|---|
| Unified social credit code | 914403006748496845 |
| Source | export sales certificate, Guangdong medical products administration |
Location
| City | Shenzhen |
|---|---|
| Province | Guangdong |
| Address | 8, Bldg 4, No.128 Shangnan East Rd., |
| Postal code | 518125 |
| Country | China |
What It Makes
| Device type | Class | Listed under the names | Listed since | Chinese makers |
|---|---|---|---|---|
| Applicator, Absorbent Tipped, Sterile | Class 1 | disposable sampling swab | 2015 | 100 |
| Container, Specimen Mailer And Storage, Non-Sterile | Class 1 | Plastic Tube | 2017 | 51 |
| Container, Specimen Mailer And Storage, Sterile | Class 1 | Plastic Tube, Swabs with Empty Tube, Dry Swab Tube | 2020 | 33 |
| Container, Specimen, Sterile | Class 1 | Plastic Tube | 2018 | 79 |
| Culture Media, Non-Propagating Transport | Class 1 | iClean Viral Transport System(VTM Kit), iClean Viral Transport System(UTM Kit), Viral Transport Media Kit(VTM Kit),, iClean Viral Transport System (VTM-RT kit),, VTM kit,Viral Transport Medium | 2022 | 11 |
| Culture Media, Non-Selective And Non-Differential | Class 1 | Culture Swab, Stuart medium, Amies medium, Cary Blair medium, | 2020 | 18 |
| General Purpose Reagent | Class 1 | Preservation Solution, Sample Collection kit, Saliva Collection kit, Normal Saline | 2020 | 30 |
Own-Brand Listings
Clearances
| Clearance | Decision date | Product code | Route | Held by |
|---|---|---|---|---|
| K212856 | 2022-08-18 | JSM | Traditional | This company |
From the Company
Published by the company on its own website, not by the FDA.
| Founded | 2008 |
|---|---|
| Employees | 300 |
| Factory area | 15000 |
| Main products | Medical sterile sampling swabs, Virus sampling tubes, Cell culture media, Nucleic acid extraction kits, Rapid test kits |
| Certifications | FDA, CE, ISO13485, GMP, 510K, EUA, MDEL, MHRA, UKCA, TGA, NMPA, Thai FDA, BSCI |
| Export markets | Global |
| OEM and ODM | Offered |
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.
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