Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3004784770

FEI Number

3004784770

Entity Name

WENZHOU DONGFANG MEDICAL INSTRUMENTS CO., LTD

City/State/Country

WENZHOU Zhejiang, CN

Establishment Address

#143, Zhongxin Road, Wenzhou Industry Zone, WENZHOU Zhejiang 325013, CN

Establishment Type(s)

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

Owner / Operator

WENZHOU KINDCARE IMPORT & EXPORT CO.,LTD (Owner Number: 9066722)

Owner / Operator Contact Address

F407,ZHANNAN COMMERCIAL & TRADING BLDG, WENZHOU, CN-ZJ 325000, CN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

KINDCARE STETHOSCOPE INJECTION PAD Tourniquet ,nonpneumatic B.P. MONITOR WITH STETHOSCOPE Blood Pressure Monitor Blood Pressure Cuff ISOLATION GOWN PENLIGHT KINDCARE OTOSCOPE Medical Respirator KN95 Mask Sand Protection Goggles Goggles Safety Goggles Medical Goggles Nursing Goggles Protective Glasses Snow Goggles

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
LDE	Stethoscope, Manual	Cardiovascular	Class 1	870.1875	2004-09-16
GAX	Tourniquet, Nonpneumatic	General, Plastic Surgery	Class 1	878.5900	2007-12-03
DXQ	Blood Pressure Cuff	Cardiovascular	Class 2	870.1120	2008-07-30
OEA	Non-Surgical Gown	General, Plastic Surgery	Class 1	878.4040	2012-03-07
ERA	Otoscope	Ear, Nose, Throat	Class 1	874.4770	2007-02-08
MSH	Respirator, Surgical	General, Plastic Surgery	Class 2	878.4040	2020-05-03
HOY	Shield, Eye, Ophthalmic (Including Sunlamp Protective Eyewear And Post-Mydriatic Eyewear)	Ophthalmic	Class 1	886.4750	2020-04-04

Official Correspondent

No official correspondent registered.

US Agent Details

Charles Mack Business: IRC USA Email: ircfda@gmail.com Phone: (931) 6254938

Related Public Records

Same Entity

WENZHOU KINDCARE IMPORT & EXPORT 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
K932506	Rudolf Riester GmbH & Co. KG	RI-SCOPE (S)	1993-10-08
K102092	Prestige Ameritech	PRO GEAR N95 PARTICULATE FILTER RESPIRATOR & SURGICAL MASK, REGULAR SIZE MODEL RP CERIES	2010-10-06

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
3031192529	Zhejiang LuDe Technology Development Co., Ltd.	Wenzhou Zhejiang, CN
3042481106	SMART HEALTH LLC	Owings Mills, MD, US
3025413691	BESTREAT SAFETY & FIRST AID SOLUTION CO., LTD	Wuhan Hubei, CN

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3004784770. Last updated year: 2026. Please use registration number 3004784770 when referencing this establishment in official correspondence.