Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3021013124

FEI Number

3021013124

Entity Name

RWD LIFE SCIENCE CO., LTD.

City/State/Country

Shenzhen Guangdong, CN

Establishment Address

19F, Building 9A, Vanke Cloud City lll, Liuxin 4 Street, Nanshan District, Shenzhen Guangdong 518000, CN

Establishment Type(s)

Export Device to the United States But Perform No Other Operation on Device,Manufacture Medical Device

Owner / Operator

RWD Life Science Co., Ltd. (Owner Number: 10089020)

Owner / Operator Contact Address

19F, Building 9A, Vanke Cloud City lll, Liuxin 4 Street, Nanshan District, Shenzhen, CN-GD 518000, CN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered 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

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
IDO	Microtome, Rotary	Pathology	Class 1	864.3010	2023-10-29
DPT	Probe, Blood-Flow, Extravascular	Cardiovascular	Class 2	870.2120	2024-05-29
IDP	Microtome, Cryostat	Pathology	Class 1	864.3010	2023-10-29
JQC	Centrifuges (Micro, Ultra, Refrigerated) For Clinical Use	Clinical Chemistry	Class 1	862.2050	2025-04-03

Official Correspondent

Xuhong Wang

US Agent Details

Bryan Wong Business: PUREVISION AI, INC. (DBA PURE GLOBAL) Email: us-agent@pureglobal.com Phone: (201) 7681688

Related Public Records

Same Entity

RWD Life Science Co., Ltd.

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0039-2012	Richard-Allan Scientific Company	1	Thermo Scientific Microm: Rotary Microtome: REF HM355S-3 Used for slicing tissue blocks.

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3021013124. Last updated year: 2026. Please use registration number 3021013124 when referencing this establishment in official correspondence.