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Healgen Scientific LLC

✓ Record-verifiedregistrations found in 9 marketsEU SRN US-MF-000018839

This company has registrations in European Union, United States, United Kingdom, Brazil, Canada, Singapore, Australia, Hong Kong, Israel — 9 overseas markets. EU UDI-DI records ≥260, 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

≥260UDI-DI device records

IVD general 207ivd-devices-self-testing 53

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

USUnited StatesFDA openFDA

77listed device types

Class I 26Class II 43Class III 0unclassified 8

plus 76 registration records and 27 510(k)

UKUnited KingdomMHRA PARD

21registered device records

IVD general 17IVD Annex II List B 1IVD Devices for Self-Testing 3

BRBrazilANVISA

0registered devices

3 including historic records

SASaudi ArabiaSFDA

0registered imported devices

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

CACanadaMDALL

52active device licences

Class II 52

90 including historic records

TWTaiwanTFDA

0valid device licences

SGSingaporeHSA SMDR

3device registrations

CLASS B 1CLASS D 2

KRSouth KoreaMFDS GMP

pendingnot queried

AUAustraliaTGA ARTG

5active ARTG entries

IVD Class 1 1IVD Class 3 4

HKHong KongMDACS

4valid listings

IVD B 1IVD C 3

ILIsraelAMAR

10registrations

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 Union693 raw hits, 40 excluded, 260 confirmed. Large result set — only the first 300 verified

United States76 registration records, 27 510(k), 0 PMA, 2 excluded

United Kingdom21 confirmed, 1 excluded

Canada52 confirmed, 1 excluded

Manufacturer names merged into this page: HEALGEN SCIENTIFIC LLC · HEALGEN SCIENTIFIC LIMITED LIABILITY COMPANY

Regulatory identity

EU manufacturer SRN: US-MF-000018839
EU authorised representative: CMC Medical Devices & Drugs SL
UK responsible person: SENSUS Group Ltd

FDA 510(k) clearances by year

12012

12013

32014

72015

12016

12017

12022

22023

42024

32025

32026

FDA listed device types

showing 8 of 77

Kit, Test, Pregnancy, Hcg, Over The Counter 1Test, Cocaine And Cocaine Metabolite, Employment And Insurance Testing, Exempt 1Enzyme Immunoassay, Opiates 1Enzyme Immunoassay, Benzodiazepine 1Simple Point-Of-Care Device To Directly Detect Sars-Cov-2 Viral Targets From Clinical Specimens In Near-Patient Settings 1Test, Propoxyphene, Over The Counter 1Thin Layer Chromatography, Methamphetamine 1Alcohol Dehydrogenase, Specific Reagent For Ethanol Enzyme Method 1

Registration details (sample)

Market	Identifier	Name	Class / date
EU	D-GGTTG-402aHGJ2	Anti-Tissue-Transglutaminase IgA Rapid Test Cassette (Whole Blood)	IVD general
EU	D-GEFTH-T625aHGSK	FOB/Transferrin/H.pylori Combo Rapid Test Device (Feces)	IVD general
EU	D-GEFB-606bHGGL	Fecal Occult Blood Rapid Test Device (Feces)	IVD general
EU	D-GCHMPV-502aHGTE	Human Metapneumovirus (HMPV) Ag Rapid Test	IVD general
UK	30517	One Step Barbiturates Test Strip (Urine)	IVD general
UK	51707	STREP A Rapid Test Cassette (Throat Swab)	IVD general
UK	60870	CHIKUNGUNYA IgM Rapid Test Cassette (Whole Blood/Serum/Plasma)	IVD general
US	K260095	Heal-Check Rapid COVID-19 Antigen Self-Test	2026-04-13
US	K253705	Healgen® Accurate Oral Fluid Drug Test	2026-03-16
US	K252523	Healgen® Accurate Oral Fluid Drug Test COT/THC; Healgen® Accurate Oral Fluid Drug Test	2026-02-12
CA	99630	ONE STEP FENTANYL TEST DIP CARD (URINE)	Class II
CA	99631	ONE STEP FENTANYL TEST CASSETTE (URINE)	Class II
CA	99645	BARBITURATES TEST CASSETTE	Class II