Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3007699082

FEI Number

3007699082

Entity Name

Shanghai Caremate Medical Device Co. Ltd

City/State/Country

Shanghai, CN

Establishment Address

Building 4, No. 281, Hong An Road, Zhujing, Shanghai 201503, CN

Establishment Type(s)

Export Device to the United States But Perform No Other Operation on Device,Manufacture Medical Device for Another Party (Contract Manufacturer),Foreign Private Label Distributor,Manufacture Medical Device

Owner / Operator

Shanghai Caremate Medical Device Co. Ltd (Owner Number: 10029174)

Owner / Operator Contact Address

Building 4, No.281 HongAn Road,Zhujing Town,Jinshan, Shanghai, CN-SH 201503, CN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Penlight Blood Pressure Cuff Blood Pressure cuff Aneroid sphygmomanometer, Aneroid sphygmomanometer with stethoscope Stethoscope STETHOSCOPE Pressure Infusor Aneroid sphygmomanometer, Aneroid sphygmomanometer with stethoscope Aneroid sphygmomanometer with stethoscope Blood Pressure 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	2015-10-20
DXQ	Blood Pressure Cuff	Cardiovascular	Class 2	870.1120	2011-02-18
DXQ	Blood Pressure Cuff	Cardiovascular	Class 2	870.1120	2022-11-21
LDE	Stethoscope, Manual	Cardiovascular	Class 1	870.1875	2022-11-21
LDE	Stethoscope, Manual	Cardiovascular	Class 1	870.1875	2010-04-13
KZD	Infusor, Pressure, For I.V. Bags	General Hospital	Class 1	880.5420	2011-12-14
DXQ	Blood Pressure Cuff	Cardiovascular	Class 2	870.1120	2009-04-13
KPY	Shield, Protective, Personnel	Radiology	Class 1	892.6500	2021-03-09

Official Correspondent

Mark Chu

US Agent Details

Marco Mu Business: MID-LINK INTERNATIONAL CO., LTD Email: us.agent@mid-link.net Phone: (702) 2095185

Related Public Records

Same Entity

Shanghai Caremate Medical Device 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

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3015438293	MACQUARIE MEDICAL SYSTEMS PVT. LTD	Leichhardt New South Wales, AU
3012499069	CANFIELD SCIENTIFIC, INC.	Parsippany, NJ, US
3012678246	TYTOCARE LTD.	Netanya Central, IL
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 3007699082. Last updated year: 2026. Please use registration number 3007699082 when referencing this establishment in official correspondence.