Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3031192529

FEI Number

3031192529

Entity Name

Zhejiang LuDe Technology Development Co., Ltd.

City/State/Country

Wenzhou Zhejiang, CN

Establishment Address

NO. 298 Jichang North Road, Longwan District, Wenzhou Zhejiang 325024, CN

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

Zhejiang LuDe Technology Development Co., Ltd. (Owner Number: 10090465)

Owner / Operator Contact Address

NO. 298 Jichang North Road, Longwan District, Wenzhou, CN-ZJ 325024, CN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K221857

PMA Number

N/A

All Registered Proprietary Names

Aneroid sphygmomanometer QL-20, QL-50, QL-201 (20A, 50A, 201C1)

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
LDE	Stethoscope, Manual	Cardiovascular	Class 1	870.1875	2024-04-01
DXQ	Blood Pressure Cuff	Cardiovascular	Class 2	870.1120	2024-04-01

Official Correspondent

Iris Du

US Agent Details

LIQIN Wang Email: Zhirui_service@163.Com Phone: (908) 3975984

Related Public Records

Same Entity

Zhejiang LuDe Technology Development 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
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
3009154535	WENZHOU KANGSHUN MEDICAL DEVICES CO.,LTD.	Wenzhou City Zhejiang, CN
3003897648	MOREPEN LABORATORIES LIMITED	Baddi, Solan Himachal Pradesh, IN
3042481106	SMART HEALTH LLC	Owings Mills, MD, US
3025413691	BESTREAT SAFETY & FIRST AID SOLUTION CO., LTD	Wuhan Hubei, CN
3009685433	AMICO DIAGNOSTIC INCORPORATED	Richmond Hill Ontario, CA

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3031192529. Last updated year: 2026. Please use registration number 3031192529 when referencing this establishment in official correspondence.