Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3015220324

FEI Number

3015220324

Entity Name

WENZHOU RENHUA INSTRUMENTS CO.,LTD

City/State/Country

WENZHOU Zhejiang, CN

Establishment Address

3rd Floor, Building 2, No.1099 Kunbei Road, Lingkun Street, Wenzhou Marine Economic Development Demonstration Zone, WENZHOU Zhejiang 325026, CN

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

WENZHOU RENHUA INSTRUMENTS CO.,LTD (Owner Number: 10059735)

Owner / Operator Contact Address

3rd Floor, Building 2, No.1099 Kunbei Road, Lingkun Street, Wenzhou Marine Economic Development Demonstration Zone, Wenzhou, CN-ZJ 325026, CN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K190902

PMA Number

N/A

All Registered Proprietary Names

Diagnostic pen light Diagnostic pen light for SPHYGMOMANOMETER DIAGNOSIS KITS, Model MAX0206 Otoscope (RH7001) Blood Pressure Meter Model Max0203 (Blue, Pink, green, gray, red, violet, yellow or Black cuff), SPHYGMOMANOMETER DIAGNOSIS KITS, Model MAX0206, Blood Pressure Meter Model Max02 (Blue, Pink, green, gray, red, violet, yellow or Black cuff), Blood Pressure Meter Model Max0202((Blue, Pink, green, gray, red, violet, yellow or Black cuff) Blood Pressure Meter Model Max0201 (Blue, Pink, green, gray, red, violet, yellow or Black cuff),

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
KYT	Light, Examination, Medical, Battery Powered	General Hospital	Class 1	880.6350	2021-01-20
ERA	Otoscope	Ear, Nose, Throat	Class 1	874.4770	2019-04-21
LDE	Stethoscope, Manual	Cardiovascular	Class 1	870.1875	2019-05-29
DXQ	Blood Pressure Cuff	Cardiovascular	Class 2	870.1120	2019-05-29

Official Correspondent

SAIJIE Wang

US Agent Details

Leeyeo Kee Business: Regrek LLC Email: regrek.cs@hotmail.com Phone: (302) 6089028

Related Public Records

Same Entity

WENZHOU RENHUA INSTRUMENTS 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
K932506	Rudolf Riester GmbH & Co. KG	RI-SCOPE (S)	1993-10-08
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

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1421873	XEMAX SURGICAL PRODUCTS, INC.	NAPA, CA, US

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3015220324. Last updated year: 2026. Please use registration number 3015220324 when referencing this establishment in official correspondence.