FDA Registration
Active
🇨🇳 China
DAKEWE(SHENZHEN) MEDICAL EQUIPMENT CO., LTD
Reg #: 3015167933
·
FEI: 3015167933
·
Expires 2026
Products
8
Proprietary Names
21
Establishment Types
2
Classifications
8
Registration Details
- Registration Name
- DAKEWE(SHENZHEN) MEDICAL EQUIPMENT CO., LTD
- Registration Number
- 3015167933
- FEI Number
- 3015167933
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- 101, 201, 301, 401, 601, 701, Building 11, Biomedical Enterprise Accelerator, 6 Linhui Road, Jinsha Community,, Kengzi, Pingshan, Shenzhen, China
- City
- Shenzhen Guangdong
- Country
- CN
Owner / Operator
- Firm Name
- Dakewe(Shenzhen) medical equipment Co., Ltd
- Operator Number
- 10059546
- Address
- 101, 201, 301, 401, 601, 701, Building 11, Biomedical Enterprise Accelerator, 6 Linhui Road, Jinsha Community,, Kengzi, Pingshan, Shenzhen, China
- City
- Shenzhen
- State
- Guangdong
- Postal Code
- 518118
- Country
- CN
- Correspondent
- YUHAO TANG
US Agent
- Business Name
- BioSci Inc.
- Contact Name
- Leiyi Zhu
- Address
- 23 Orchard Rd Ste 202
- City
- Skillman
- State
- NJ
- ZIP
- 08558
- Country
- US
- [email protected]
- Phone
- 916 7760136
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Container, Embedding | KER | Class 1 | Pathology | No | 2021-06-18 |
| Slide Stainer, Automated | KPA | Class 1 | Pathology | No | 2019-01-31 |
| Processor, Tissue, Automated | IEO | Class 1 | Pathology | No | 2019-01-31 |
| Coverslips, Microscope Slide | KES | Class 1 | Pathology | No | 2020-01-20 |
| Microtome, Cryostat | IDP | Class 1 | Pathology | No | 2019-01-31 |
| Microtome, Rotary | IDO | Class 1 | Pathology | No | 2019-01-31 |
| Device For Sealing Microsections | KIM | Class 1 | Pathology | No | 2019-06-03 |
| Slides, Microscope | KEW | Class 1 | Pathology | No | 2021-06-18 |
Proprietary Names
Embedding Cassette C02
Embedding Cassette C01
Embedding Cassette C03
Embedding Cassette C00
DP260; DP360
Fully Automated IHC Stainer NS40; NS20
HP300 Automatic tissue processor
HP300 Plus Automatic tissue processor
HP-HUGO Automatic tissue processor
0300911-00 Microscope Cover Glass
CG0121019 Microscope Cover Glass
6250 Cryostat Microtome
CT520 Cryostat Microtome
CT620 Cryostat Microtome
MT1 ROTARY MICROTOME
Glass coverslipper
CS500
Glass Coverslipper CS600
Adhesion Microscope Slides DKWAS001A
Microscope Slides 7109030A
Microscope Slide 7109040A
Establishment Types
Repack or Relabel Medical Device
Manufacture Medical Device