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Assure Tech LLC

USA · Wilmington DE · www.assuretechusa.com

✓ Record-verifiedregistrations found in 8 marketsEU SRN CN-MF-000002170

This company has registrations in European Union, United States, United Kingdom, Brazil, Canada, South Korea, Australia, Hong Kong — 8 overseas markets. EU UDI-DI records ≥159, the first 300 verified individually. The China NMPA lookup is still pending.

Registrations by market

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

CNChinaNMPA

n/aThis registry lists domestic registrants only

EUEuropean UnionEUDAMED

≥159UDI-DI device records

IVD A 26IVD B 15IVD C 38IVD general 78ivd-devices-self-testing 2

large result set — only the first 300 records were verified, so the real figure is at least this

USUnited StatesFDA openFDA

54listed device types

Class I 13Class II 37Class III 0unclassified 4

plus 127 registration records and 17 510(k)

UKUnited KingdomMHRA PARD

183registered device records

IVD A 3IVD C 1IVD general 169IVD Annex II List A 1IVD Annex II List B 1IVD Devices for Self-Testing 8

BRBrazilANVISA

68registered devices

Class II 68

97 including historic records

SASaudi ArabiaSFDA

0registered imported devices

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

CACanadaMDALL

0active device licences

123 including historic records

TWTaiwanTFDA

0valid device licences

SGSingaporeHSA SMDR

pendingnot queried

KRSouth KoreaMFDS GMP

1GMP quality-system certificates

IVD import 1

AUAustraliaTGA ARTG

6active ARTG entries

IVD Class 3 6

HKHong KongMDACS

1valid listings

IVD C 1

ILIsraelAMAR

pendingnot queried

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 Union644 raw hits, 141 excluded, 159 confirmed. Large result set — only the first 300 verified

United States127 registration records, 17 510(k), 0 PMA, 3 excluded

United Kingdom183 confirmed, 4 excluded

Brazil68 confirmed, 1 excluded

Saudi Arabia0 confirmed, 1 excluded

Canada0 confirmed, 1 excluded

Manufacturer names merged into this page: ASSURE TECH. (HANGZHOU) CO., LTD. · Assure Tech. (Hangzhou) Co., Ltd. · ASSURE TECH LLC · ASSURE TECH. (HANGZHOU) CO. LTD. · ASSURE TECH. (HANGZHOU) CO., LTD · ASSURE TECH (HANGZHOU) CO., LTD

Regulatory identity

EU manufacturer SRN: CN-MF-000002170
EU authorised representative: CMC Medical Devices & Drugs SL
UK responsible person: Medimap Ltd

FDA 510(k) clearances by year

22015

32016

12017

22018

12021

22024

42025

22026

FDA listed device types

showing 8 of 54

Kit, Test, Pregnancy, Hcg, Over The Counter 1Test, Cocaine And Cocaine Metabolite, Employment And Insurance Testing, Exempt 1Enzyme Immunoassay, Opiates 1Enzyme Immunoassay, Benzodiazepine 1Test, Propoxyphene, Over The Counter 1Thin Layer Chromatography, Methamphetamine 1Test, Tricyclic Antidepressants, Over The Counter 1Test, Benzodiazepine, Over The Counter 1

Registration details (sample)

Market	Identifier	Name	Class / date
EU	06952804838591	—	IVD B
EU	06952804838539	—	IVD B
EU	06952804838416	—	IVD B
EU	06952804838294	—	IVD B
UK	42656	a-pvp Rapid Test	IVD general
UK	64154	6-Monoacetylmorphine Rapid Test	IVD general
UK	64160	Acetaminophen Rapid Test	IVD general
US	K261984	AssureTech Quick Cup Tests;AssureTech Multi-drug Urine Test Cup	2026-07-17
US	K260754	Fastep COVID-19 Antigen Pen Home Test; Fastep COVID-19 Antigen Pen Test	2026-06-05
US	K252259	AssureTech Quick Cup Tests; AssureTech Multi-drug Urine Test Cup	2025-08-15
BR	80113770064	Família Teste de Gravidez	Class II
BR	80885650026	Multi 3 Assure Test + Alcohol	Class II
BR	80885650088	Monitor de Glicemia Acuteck	Class II

Assure Tech LLC

Registrations by market

How these numbers were verified

Regulatory identity

Company information

FDA 510(k) clearances by year

FDA listed device types

Registration details (sample)

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