Shenzhen Dakewe BIO-Engineering Co., Ltd.
Manufacturer and brand owner in Shenzhen, Guangdong, China. 7 device types, 13 products catalogued, 3 clearances.
Shenzhen Dakewe BIO-Engineering Co., Ltd. is a manufacturer holding a current FDA establishment registration. The registration covers Eosin Y, Hematoxylin and 5 other device types. 13 of its products are catalogued under its own name. Its earliest product listing with the FDA dates from 2020.
7device types registered with the FDA
13products catalogued under its own name
3510(k) clearances
Registration
| Registered name | SHENZHEN DAKEWE BIO-ENGINEERING CO., LTD. |
|---|---|
| Status | Registered |
| Registration expires | 2026 |
| Registration number | 3017170972 |
| FEI number | 3017170972 |
| DUNS | 543029175 |
| Establishment type | Manufacturer |
Chinese Registration
| Chinese legal name | 深圳市达科为生物工程有限公司 |
|---|---|
| Unified social credit code | 914403005879322954 |
| Source | NMPA UDI database |
Location
| City | Shenzhen |
|---|---|
| Province | Guangdong |
| Address | Room702.703,Building No.1 Shenzhen Biomedicine Innovations Industrial Park No.14 Jinhui Road,Kengzi Street |
| Postal code | 518122 |
| Country | China |
What It Makes
| Device type | Class | Listed under the names | Listed since | Chinese makers |
|---|---|---|---|---|
| Clinical Sample Concentrator | Class 1 | Nucleic Acid Extraction Reagent(100T/Kit,500T/Kit,96T/Kit,16T/Kit) | 2020 | 27 |
| Culture Media, Non-Selective And Non-Differential | Class 1 | Sterile Phosphate Buffered Saline, Sterile Normal Saline, SNT Biotech Sterile Normal Saline | 2020 | 18 |
| Eosin Y | Class 1 | Eosin Staining Solution, Water-soluble, BioSci™Eosin Staining Solution | 2023 | 4 |
| General Purpose Reagent | Class 1 | Wash Solution, Probe Cleaning Solution, Antigen Solution Retrieval, Dewax Solution | 2024 | 30 |
| Hematoxylin | Class 1 | Hematoxylin Staining Solution, I, BioSci™Hematoxylin Staining Solution | 2023 | 3 |
| Immunohistochemistry Reagents And Kits | Class 1 | Immunochromogenic Reagent, Ki-67 Antibody Reagent | 2024 | 7 |
| Mounting Media | Class 1 | Mounting Medium, NB-30 | 2021 | 1 |
Own-Brand Listings
| Product | Code | Catalogue numbers |
|---|---|---|
| BioSci | JSM | 27 |
| Dakewe | QBD | 12 |
| Dakewe | NJT | 6 |
| Dakewe | PPM | 6 |
| SNT Biotech | KXG | 4 |
| Biosci™ | QMC | 3 |
| BioSci™ | QBD | 3 |
| SNT Biotech | JSM | 2 |
| Biosci™ | KXG | 2 |
| SNT Biotech | QMC | 2 |
| Dtpm | QBD | 2 |
| BioSci™ | HYB | 1 |
| BioSci™ | HYJ | 1 |
Clearances
| Clearance | Decision date | Product code | Route | Held by |
|---|---|---|---|---|
| K240235 | 2024-08-19 | JSM | Traditional | This company |
| K230035 | 2023-04-05 | JSM | Traditional | This company |
| K220059 | 2023-01-19 | QBD | Traditional | This company |
From the Company
Published by the company on its own website, not by the FDA.
| Founded | 1999 |
|---|---|
| Employees | 791 |
| Main products | Life science research instruments, Medical diagnostic reagents, Pathology diagnostic technology, Cell therapy technology, Blood transfusion technology |
| Export markets | Hong Kong, Taiwan, Southeast Asia, North America |
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.
The manufacturer named here can complete this record.