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Shenzhen URION Technology Co.,Ltd

China · Shenzhen Guangdong · www.urionsz.com

✓ Record-verifiedregistrations found in 10 marketsEU SRN CN-MF-000018740Unified social credit code 91440300571971732H

This company holds 5 NMPA certificates in China and has registrations in European Union, United States, United Kingdom, Brazil, Taiwan, South Korea, Australia, Hong Kong, Israel — 9 overseas markets.

Registrations by market

Each market counts a different unit; figures are not directly comparable

CNChinaNMPA

5China registrations

Class I 1Class II 4

as of 2026-09-04

EUEuropean UnionEUDAMED

156UDI-DI device records

Class IIa 156

USUnited StatesFDA openFDA

9listed device types

Class I 5Class II 4Class III 0

plus 14 registration records and 8 510(k)

UKUnited KingdomMHRA PARD

10registered device records

Class IIa 10

BRBrazilANVISA

1registered devices

Class II 1

this export covers Class I / II only (the cadastro route)

SASaudi ArabiaSFDA

0registered imported devices

low-risk imported devices only; a 2023 snapshot, not updated since

CACanadaMDALL

0active device licences

TWTaiwanTFDA

1valid device licences

Class II 1

SGSingaporeHSA SMDR

pendingnot queried

KRSouth KoreaMFDS GMP

1GMP quality-system certificates

Import 1

AUAustraliaTGA ARTG

19active ARTG entries

IIa 19

HKHong KongMDACS

1valid listings

Class II 1

ILIsraelAMAR

3registrations

RURussiaRoszdravnadzor

pendingnot queried

Not yet connected: India CDSCO, Indonesia Kemenkes. The public search for Japan PMDA and Vietnam IMDA does not return manufacturer names, so entries cannot be linked to companies coming — where there is no data it is shown as "pending", never estimated.

How these numbers were verified

record-verified

Company-name search in every official database is a substring match and returns same-named but different companies. Each figure below is the count after re-checking every record against the manufacturer name.

European Union212 raw hits, 56 excluded, 156 confirmed

United States14 registration records, 8 510(k), 0 PMA

China5 certificates (Class III 0 / II 4 / I 1), as of 2026-09-04

United Kingdom10 confirmed, 3 excluded

Brazil1 confirmed, 0 excluded

Manufacturer names merged into this page: SHENZHEN URION TECHNOLOGY CO., LTD. · SHENZHEN URION TECNNOLOGY CO., LTD

Regulatory identity

EU manufacturer SRN: CN-MF-000018740
EU authorised representative: Wellkang Ltd
UK responsible person: Wellkang Ltd
Unified social credit code: 91440300571971732H
Exhibition record: CMEF 87th (Spring 2023, Shanghai) · CMEF 89th (Apr 2024, Shanghai) · CMEF 93rd (Apr 2026, Shanghai)

Business registration

Registration status: Active
Incorporated: 2011-03-18
Registered capital: CNY 25,000,000
Paid-in capital: CNY 25,000,000
Legal form: Limited liability company
Industry classification: Special-purpose equipment manufacturing
Last approval date: 2025-03-31
Recognitions: Micro and small enterpriseNational High-Tech Enterprise

Business registration data from Tianyancha, as of 2026-09-02. Public registry information only; legal representative and contact-person details are not collected. The figure is the number of employees enrolled in social insurance as declared by the company, which may differ from actual headcount.

FDA 510(k) clearances by year

12015 · K141683

12016 · K160019

12020 · K200802

12024 · K241007

22025 · K250046

22026 · K254048

FDA listed device types

showing 8 of 9

Toothbrush, Powered 1Scale, Platform, Wheelchair 1Adult Portable Bed Rails For Medical Purposes 1Pump, Nebulizer, Electrically Powered 1Massager, Therapeutic, Electric 1Lamp, Infrared, Therapeutic Heating 1Continuous Measurement Thermometer 1Massager, Powered Inflatable Tube 1

Registration details (sample)

Market	Identifier	Name	Class / date
CN	粤械注准20262070686	腕式电子血压计	Class II
CN	粤械注准20172071157	腕式电子血压计	Class II
CN	粤械注准20172071155	臂式电子血压计	Class II
CN	粤械注准20162071205	红外体温计	Class II
EU	06953825911362	Upper Arm ElectronicBlood Pressure Monitor	Class IIa
EU	06953825911713	intec Upper Arm Electronic Blood Pressure Monitor	Class IIa
EU	06953825911621	Alphamed Wrist Watch Electronic Blood Pressure Monitor	Class IIa
EU	06953825911614	Alphamed Wrist Watch Electronic Blood Pressure Monitor	Class IIa
UK	45617	Digital Blood Pressure Monitors	Class IIa
UK	45617	Upper Arm Electronic Blood Pressure Monitor	Class IIa
UK	63711	Infrared Thermometer	Class IIa
US	K254048	Wrist Watch Electronic Blood Pressure Monitor (U16H, U16L, U16P, U16W, U19M, U19R, U19S, and U19T)	2026-05-14
US	K260273	Automatic Electronic Blood Pressure Monitor (U90B series models including ( U90B,U90B Pro,U90B Plus,U90B Ultra,U90C,U90C Pro,U90C Plus,U90C Ultra).)	2026-03-26
US	K250046	Air Compression Leg Massager (UM605, UM606, UM607, UM608,UM609,UM610, UM611, UM617)	2025-04-25
BR	82604869001	Termômetro digital Infravermelho	Class II

Shenzhen URION Technology Co.,Ltd

Registrations by market

How these numbers were verified

Regulatory identity

Company information

Business registration

FDA 510(k) clearances by year

FDA listed device types

Registration details (sample)

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