Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3016170326

FEI Number

3016170326

Entity Name

ZHUHAI LINTE MEDICAL INSTRUMENT CO., LTD.

City/State/Country

Zhuhai Guangdong, CN

Establishment Address

501, Building #3, 2 Jinliang Road, Hongqi Town, Jinwan District, Zhuhai Guangdong 519090, CN

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

Zhuhai Linte Medical Instrument Co., Ltd. (Owner Number: 10061578)

Owner / Operator Contact Address

501, Building #3, 2 Jinliang Road, Hongqi Town, Jinwan District, Zhuhai, CN-GD 519090, CN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K220220

PMA Number

N/A

All Registered Proprietary Names

AS series pulse oximeter: LT-AS series Handheld pulse oximeter: LT-H series Fingertip pulse oximeter: LT-F series, LT-F20, LT-F21, LT-F30, LT-F31, LT-F50, LT-F51, LT-F60, LT-F61 Upper Arm Blood Pressure Monitor/ Model: BU 420, Brand Name: Medisana Blood Pressure Monitor/ Model: LT-P30, LT-P30A, LT-P31, LT-P31A, LT-P35, LT-P50, LT-P51, LT-P70, LT-P71 Blood Pressure Monitor/ Model: PH-PMDBPAMP, Brand Name: Proheal

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
OCH	Oximeter, Infrared, Sporting, Aviation	Cardiovascular	Class 2	870.2700	2019-10-30
DXN	System, Measurement, Blood-Pressure, Non-Invasive	Cardiovascular	Class 2	870.1130	2022-10-16

Official Correspondent

Chunxiu Sun

US Agent Details

Da Yi Email: yi.da1@outlook.com Phone: (617) 5167827

Related Public Records

Same Entity

Zhuhai Linte Medical Instrument 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
K100940	Andon Health Co, Ltd.	FULLY AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR, MODEL KD-5965	2010-06-29
K251581	Shenzhen Hingmed Medical Instrument Co., Ltd.	Wearable Ambulatory Blood Pressure Monitor (WBP-02A)	2026-02-13
K200521	Health & Life Co., Ltd.	Full Automatic(NIBP) Blood Pressure Monitor	2020-06-12
K152003	Andon Health Co, Ltd.	iHealth BP3L Wireless Blood Pressure Monitor	2015-09-24
K952827	Sein Electronics Co., Ltd.	FULL AUTO WRIST BLOOD PRESSURE METER MODEL SE-5000	1996-11-14

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0032-2025	MEDLINE INDUSTRIES, LP Northfield	2	MEDLINE AUTOMATIC DIGITAL BLOOD PRESSURE UNIT, REF MDS1001
Z-0033-2025	MEDLINE INDUSTRIES, LP Northfield	2	MEDLINE AUTOMATIC DIGITAL BLOOD PRESSURE UNIT, REF MDS1001U.
Z-0034-2025	MEDLINE INDUSTRIES, LP Northfield	2	MEDLINE Automatic Digital Blood Pressure Monitor, REF MDS1001UT.

Similar Registrations

Registration Number	Establishment Name	Location
3008830133	SHENZHEN AEON TECHNOLOGY CO.,LTD	shenzhen Guangdong, CN
3013545943	Prime Med Shop LLC	Stafford, TX, US
3016859940	JIANGSU KONSUNG BIO-MEDICAL SCIENCE AND TECHNOLOGY CO LTD	Danyang Jiangsu, CN
3009327812	Proactive Medical Products	Mount Vernon, NY, US
3017207990	SHENZHEN YUEZHONGXING TECHNOLOGY CO.,LTD	Huizhou Guangdong, CN

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3016170326. Last updated year: 2026. Please use registration number 3016170326 when referencing this establishment in official correspondence.