Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3008962161

FEI Number

3008962161

Entity Name

WENZHOU NAISI HEALTH PRODUCT CO., LTD.

City/State/Country

Wenzhou City Zhejiang, CN

Establishment Address

Building 30-31, Ni Yu Garden, Ni Sheng Road 2000, Dongtou District, Wenzhou City Zhejiang 325702, CN

Establishment Type(s)

Manufacture Medical Device for Another Party (Contract Manufacturer)

Owner / Operator

Wenzhou Naisi Health Product Co., Ltd. (Owner Number: 10035491)

Owner / Operator Contact Address

Building 30-31, Ni Yu Garden, Ni Sheng Road 2000, Dongtou District, Wenzhou City, CN-ZJ 325702, CN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Medline Singe Patient Use Blood Pressure Cuff Medline blood pressure cuff

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
DXQ	Blood Pressure Cuff	Cardiovascular	Class 2	870.1120	2022-04-07
DXQ	Blood Pressure Cuff	Cardiovascular	Class 2	870.1120	2011-03-01

Official Correspondent

No official correspondent registered.

US Agent Details

Rosanna Lee Business: Simcon International LLC Email: rlee@simconintl.com Phone: (847) 9492290

Related Public Records

Same Entity

Wenzhou Naisi Health Product 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
3031192529	Zhejiang LuDe Technology Development Co., Ltd.	Wenzhou Zhejiang, CN
3002865611	BALLERSTEDT GMBH	Reinbek Schleswig-Holstein, DE
3009154535	WENZHOU KANGSHUN MEDICAL DEVICES CO.,LTD.	Wenzhou City Zhejiang, CN
1058002	Technicuff Corp.	LEESBURG, FL, US
3001570235	GE Medical Systems Information Technologies, Inc.	Waukesha, WI, US

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3008962161. Last updated year: 2026. Please use registration number 3008962161 when referencing this establishment in official correspondence.