FDA Registration
Active
🇨🇳 China
HUACHENYANG(SHENZHEN)TECHNOLOGY CO., LTD
Reg #: 3011649813
·
FEI: 3011649813
·
Expires 2026
Products
7
Proprietary Names
8
Establishment Types
1
Classifications
7
Registration Details
- Registration Name
- HUACHENYANG(SHENZHEN)TECHNOLOGY CO., LTD
- Registration Number
- 3011649813
- FEI Number
- 3011649813
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- 8, Bldg 4, No.128 Shangnan East Rd.,, Huangpu Community, XingiaoSt., Bao'an
- City
- Shenzhen Guangdong
- Country
- CN
Regulatory Submissions
- 510(k) Number
- K212856
Owner / Operator
- Firm Name
- Huachenyang(Shenzhen)Technology Company Ltd
- Operator Number
- 10048986
- Address
- 8F, Bldg 4,128# Shangnan East Rd, Bao'an
- City
- Shenzhen
- State
- Guangdong
- Postal Code
- 518125
- Country
- CN
- Correspondent
- Oliver Hou
US Agent
- Business Name
- Regrek LLC
- Contact Name
- Leeyeo Kee
- Address
- 19 Holly Cove Ln.,
- City
- Dover
- State
- DE
- ZIP
- 19901
- Country
- US
- [email protected]
- Phone
- 302 6089028
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Culture Media, Non-Selective And Non-Differential | JSG | Class 1 | Microbiology | No | 2020-05-01 |
| Container, Specimen, Sterile | FMH | Class 1 | Pathology | No | 2018-12-30 |
| General Purpose Reagent | PPM | Class 1 | Pathology | No | 2020-01-08 |
| Culture Media, Non-Propagating Transport | JSM | Class 1 | Microbiology | No | 2022-08-31 |
| Container, Specimen Mailer And Storage, Non-Sterile | NNK | Class 1 | Pathology | No | 2017-06-29 |
| Container, Specimen Mailer And Storage, Sterile | KDT | Class 1 | Pathology | No | 2020-05-01 |
| Applicator, Absorbent Tipped, Sterile | KXG | Class 1 | General Hospital | No | 2015-03-30 |
Proprietary Names
Culture Swab, Stuart medium, Amies medium, Cary Blair medium,
Plastic Tube
Preservation Solution, Sample Collection kit, Saliva Collection kit, Normal Saline
iClean Viral Transport System(VTM Kit), iClean Viral Transport System(UTM Kit), Viral Transport Media Kit(VTM Kit),
VTM kit,Viral Transport Medium
iClean Viral Transport System (VTM-RT kit),
Plastic Tube, Swabs with Empty Tube, Dry Swab Tube
disposable sampling swab
Establishment Types
Manufacture Medical Device