Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3011654863

FEI Number

3011654863

Entity Name

SHENZHEN URION TECHNOLOGY CO., LTD.

City/State/Country

Shenzhen Guangdong, CN

Establishment Address

Floor 4th-6th of Building D , Jiale Science&Technology Industrial Zone, No.3 , ChuangWei Road ,Heshuikou, Community,MaTian St.,GuangMing New District, Shenzhen Guangdong 518106, CN

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

Shenzhen Urion Technology Co., Ltd. (Owner Number: 10049394)

Owner / Operator Contact Address

Floor 4th-6th of Building D , Jiale Science&Technology Industrial Zone, No.3 , ChuangWei Road ,, Heshuikou Community,MaTian Street,GuangMing New District, Shenzhen, CN-GD 518106, CN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K160019

PMA Number

N/A

All Registered Proprietary Names

Nebulizer ISA - Neck massager,therapeutic,electric ISA - Leg Massager, therapeutic, electric BED RAIL Upper Arm Electronic Blood Pressure Monitor U90B, U90B Pro, U90B Plus, U90B Ultra Automatic Electronic Blood Pressure Monitor U90C, U90C Pro, U90C Plus, U90C Ultra Upper Arm Electronic Blood Pressure Monitor U90C, U90C Pro, U90C Plus, U90C Ultra Automatic Electronic Blood Pressure Monitor U90B, U90B Pro, U90B Plus, U90B Ultra Air Compression Leg Massager (UM605,UM606, UM607,UM608,UM609,UM610,UM611,UM617) Andesfit Ltd ADF-B33A UFR103,UFR116,UFR205,UFR105,UFR201 UFR102 Red Light Support Belt RL 450, RL 450G, RL 450B, RL 600, RL 600G, RL 600B, G78B, G15 Red Light Belt RL 500, RL 500B, RL 500G, RL 550, RL 550B, RL 550G, G78 BU A55,BU A57,BU 510,BU 512,BU 514,BU 516 ZYBS MEDICAL UPPER ARM ELECTRONIC MONITOR MODEL: U80B U82W, U807, U81Q, U80W, U80G Upper Arm Electronic Blood Pressure Monitor U80A,U80AH,U80B,U80BH U80M,U81M,U82H,U83H,U85H U80L,U80T,U81K,U80CH,U81CH,U80I U80K,U80NH,U80R,U80IH,U81H,U80H,U80LH,U82NH U80C U90E,U91E,U92E,U90F,U91F,U92F,U80V,U82V Medisana upper arm blood pressure monitor BU 630

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
JPW	Pump, Nebulizer, Electrically Powered	Ear, Nose, Throat	Class 1	874.5220	2024-04-28
ISA	Massager, Therapeutic, Electric	Physical Medicine	Class 1	890.5660	2022-08-27
INF	Scale, Platform, Wheelchair	Physical Medicine	Class 1	890.3940	2022-03-01
QTC	Adult Portable Bed Rails For Medical Purposes	Physical Medicine	Class 1	890.5050	2023-05-24
DXN	System, Measurement, Blood-Pressure, Non-Invasive	Cardiovascular	Class 2	870.1130	2026-04-02
IRP	Massager, Powered Inflatable Tube	Physical Medicine	Class 2	890.5650	2025-04-29
FLL	Continuous Measurement Thermometer	General Hospital	Class 2	880.2910	2020-10-09
ILY	Lamp, Infrared, Therapeutic Heating	Physical Medicine	Class 2	890.5500	2024-05-22
DXN	System, Measurement, Blood-Pressure, Non-Invasive	Cardiovascular	Class 2	870.1130	2016-05-03

Official Correspondent

No official correspondent registered.

US Agent Details

David Lennarz Business: Registrar Corp Email: David.Lennarz@registrarcorp.com Phone: (757) 2240177

Related Public Records

Same Entity

Shenzhen Urion Technology 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.

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3013683058	DISPOSAFE HEALTH AND LIFE CARE LIMITED	Faridabad Haryana, IN
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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3011654863. Last updated year: 2026. Please use registration number 3011654863 when referencing this establishment in official correspondence.