FDA Registration
Active
🇨🇳 China
RWD LIFE SCIENCE CO., LTD.
Reg #: 3021013124
·
FEI: 3021013124
·
Expires 2026
Products
4
Proprietary Names
16
Establishment Types
2
Classifications
4
Registration Details
- Registration Name
- RWD LIFE SCIENCE CO., LTD.
- Registration Number
- 3021013124
- FEI Number
- 3021013124
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- 19F, Building 9A, Vanke Cloud City lll, Liuxin 4 Street, Nanshan District
- City
- Shenzhen Guangdong
- Country
- CN
Regulatory Submissions
- 510(k) Number
- K233076
Owner / Operator
- Firm Name
- RWD Life Science Co., Ltd.
- Operator Number
- 10089020
- Address
- 19F, Building 9A, Vanke Cloud City lll, Liuxin 4 Street, Nanshan District
- City
- Shenzhen
- State
- Guangdong
- Postal Code
- 518000
- Country
- CN
- Correspondent
- Xuhong Wang
US Agent
- Business Name
- PUREVISION AI, INC. (DBA PURE GLOBAL)
- Contact Name
- Bryan Wong
- Address
- 111 Town Square Pl Ste 1203
- City
- Jersey City
- State
- NJ
- ZIP
- 07310
- Country
- US
- [email protected]
- Phone
- 201 7681688
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Microtome, Rotary | IDO | Class 1 | Pathology | No | 2023-10-29 |
| Probe, Blood-Flow, Extravascular | DPT | Class 2 | Cardiovascular | No | 2024-05-29 |
| Microtome, Cryostat | IDP | Class 1 | Pathology | No | 2023-10-29 |
| Centrifuges (Micro, Ultra, Refrigerated) For Clinical Use | JQC | Class 1 | Clinical Chemistry | No | 2025-04-03 |
Proprietary Names
Rotary Microtome S700A
Rotary Microtome S710
Rotary Microtome S712
Rotary Microtome S700
Rotary Microtome
Extravascular Blood Flow Probe
Laser Speckle Imaging System (RFLSI CZW)
Cryostat FS800A
Cryostat
Cryostat FS800
M1324
M1324R
Microcentrifuge
High-Speed Benchtop Refrigerated Centrifuge
Refrigerated microcentrifuge
M1416R
Establishment Types
Manufacture Medical Device
Export Device to the United States But Perform No Other Operation on Device