Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3022543477

FEI Number

3022543477

Entity Name

SHENZHEN PRUNUS MEDICAL CO.,LTD.

City/State/Country

shenzhen Guangdong, CN

Establishment Address

6th Floor,8th Floor and 9th Floor,No.71-3,Xintian Road, Xintian Community, Fuhai Street, shenzhen Guangdong 518103, CN

Establishment Type(s)

Manufacture Medical Device for Another Party (Contract Manufacturer)

Owner / Operator

Shenzhen Prunus Medical Co.,Ltd. (Owner Number: 10084661)

Owner / Operator Contact Address

6th Floor, 8th Floor and 9th Floor, No. 71-3, Xintian Road, Xintian Community, Fuhai Street, Bao'an District, shenzhen, CN-GD 518103, CN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Gas-machine, anesthesia Gas-machine, anesthesia

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
BSZ	Gas-Machine, Anesthesia	Anesthesiology	Class 2	868.5160	2024-12-02
BSZ	Gas-Machine, Anesthesia	Anesthesiology	Class 2	868.5160	2025-12-23

Official Correspondent

Huang Yangchun

US Agent Details

CHUNHONG LAI Email: fg@prunusmedical.com Phone: (415) 6551928

Related Public Records

Same Entity

Shenzhen Prunus Medical Co.,Ltd.

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

View Entity Profile →

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K252746	Drägerwerk AG Co. Kgaa	Atlan (A100); Atlan (A100 XL); Atlan(A350); Atlan (A350 XL)	2026-05-21

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0008-2011	GE Healthcare, LLC	2	GE Datex-Ohmeda Aisys Anesthesia System, manufactured by GE Healthcare, P.O. Box 900, FIN-00031 GE, Finland
Z-0008-2014	Draeger Medical, Inc.	2	Draeger Fabius GS Premium, Fabius OS, Fabius Tiro, Fabius Tiro D-M Product Usage: used to administer anesthesia and ventilation to patients during surgical procedures.
Z-0009-2011	GE Healthcare, LLC	2	GE Datex-Ohmeda Avance Anesthesia System, manufactured by GE Healthcare, P.O. Box 900, FIN-00031 GE, Finland
Z-0009-2014	GE Healthcare, LLC	2	GE Healthcare, Aisys, Amingo, Avance, and Avance CS2. Intended for volume or pressure control ventilation.
Z-0010-2011	GE Healthcare, LLC	2	GE Datex-Ohmeda Amingo Anesthesia System, manufactured by GE Healthcare, P.O. Box 900, FIN-00031 GE, Finland

Similar Registrations

Registration Number	Establishment Name	Location
2518157	PRECISION FLUIDICS DIVISION PARKER HANNIFIN CORP.	HATFIELD, PA, US
9611500	Draegerwerk AG & Co. KGaA	LUEBECK Schleswig-Holstein, DE
2112667	Datex-Ohmeda, Inc.	MADISON, WI, US
3003589956	Flextronics Manufacturing (Singapore) Pte Ltd	SINGAPORE South East, SG
3005803793	THORNHILL RESEARCH INC.	TORONTO Ontario, CA

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3022543477. Last updated year: 2026. Please use registration number 3022543477 when referencing this establishment in official correspondence.