Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3011529836

FEI Number

3011529836

Entity Name

Suzhou Minhua Medical Equipment Co.,Ltd.

City/State/Country

SuZhou Jiangsu, CN

Establishment Address

No. 789 Wufang Road YouYi Industrial Park, SuZhou Jiangsu 215222, CN

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

Suzhou Minhua Medical Equipment Co.,Ltd. (Owner Number: 10048668)

Owner / Operator Contact Address

No. 789 Wufang Road YouYi Industrial Park, Suzhou, CN-JS 215222, CN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Reusable Blood Pressure Cuff Over-The-Counter Use NBP Cuff for Adult; NBP Cuff for Child; NBP Cuff for Infant; NBP Cuff for Neonates; NBP extension hose /adapter Medline Reusable Blood Pressure Cuff

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
JOW	Sleeve, Limb, Compressible	Cardiovascular	Class 2	870.5800	2026-04-30
DXQ	Blood Pressure Cuff	Cardiovascular	Class 2	870.1120	2024-01-25
IMP	Cushion, Wheelchair	Physical Medicine	Class 1	890.3920	2022-11-09
IKY	Mattress, Flotation Therapy, Non-Powered	General Hospital	Class 1	880.5150	2023-09-21
DXQ	Blood Pressure Cuff	Cardiovascular	Class 2	870.1120	2023-02-22
FMP	Protector, Skin Pressure	General Hospital	Class 1	880.6450	2017-04-18
JOW	Sleeve, Limb, Compressible	Cardiovascular	Class 2	870.5800	2018-09-13
DXQ	Blood Pressure Cuff	Cardiovascular	Class 2	870.1120	2022-11-09
DXQ	Blood Pressure Cuff	Cardiovascular	Class 2	870.1120	2018-07-11
DXQ	Blood Pressure Cuff	Cardiovascular	Class 2	870.1120	2018-01-30
JOW	Sleeve, Limb, Compressible	Cardiovascular	Class 2	870.5800	2021-08-03
DXQ	Blood Pressure Cuff	Cardiovascular	Class 2	870.1120	2015-05-18
CCX	Support, Patient Position	Anesthesiology	Class 1	868.6820	2021-12-08
KZD	Infusor, Pressure, For I.V. Bags	General Hospital	Class 1	880.5420	2015-02-10

Official Correspondent

No official correspondent registered.

US Agent Details

David Lennarz Business: Registrar Corp Email: David.Lennarz@registrarcorp.com Phone: (757) 2240177

Related Public Records

Same Entity

Suzhou Minhua Medical Equipment 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
K170216	Tactile Systems Technology, Inc. (Dba Tactile Medical)	Flexitouch System	2017-05-26
K100306	Covidien	KENDALL SCD SEQUENTIAL COMPRESSION COMFORT SLEEVES	2010-05-04
K831001	Frontier Products	UNICUFF-BLOOD PRESSURE CUFF	1983-07-28
K253089	Shenzhen Best Electronics Co., Ltd.	NIBP Cuff (BCS-112, BCS-212, BCS-312, BCS-412, BCS-512, BCS-612, BCS-712, BCS-122, BCS-222, BCS-322, BCS-422, BCS-522, BCS-622, BCS-722, BCD-112, BCD-212, BCD-312, BCD-412, BCD-512, BCD-612, BCD-712, BCD-122, BCD-222, BCD-322, BCD-422, BCD-522, BCD-622, BCD-722)	2026-02-13
K972301	Rudolf Riester GmbH & Co. KG	BIG BEN SQUARE, BIG BEN ROUND	1997-09-17

Similar Registrations

Registration Number	Establishment Name	Location
3033981998	KOYA MEDICAL, INC.	Dallas, TX, US
3020703724	Therma Bright Inc.	Toronto Ontario, CA
3014491159	AIROS MEDICAL INC	Audubon, PA, US
3014834638	ZENITH TECHNICAL INNOVATIONS, LLC	Gurnee, IL, US
3009155917	GRANDWAY TECHNOLOGY (SHENZHEN) LIMITED	Shenzhen Guangdong, CN

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3011529836. Last updated year: 2026. Please use registration number 3011529836 when referencing this establishment in official correspondence.