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Argon Medical Devices, Inc.

✓ Record-verifiedregistrations found in 12 marketsEU SRN US-MF-000002324

This company has registrations in European Union, United States, United Kingdom, Brazil, Canada, Taiwan, Singapore, South Korea, Australia, Hong Kong, Israel, Russia — 12 overseas markets. EU UDI-DI records ≥300, 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

≥300UDI-DI device records

Class I 35Class IIa 247Class III 18

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

USUnited StatesFDA openFDA

90listed device types

Class I 29Class II 59Class III 0unclassified 2

plus 217 registration records and 53 510(k)

UKUnited KingdomMHRA PARD

54registered device records

Class I 7Class IIa 21Class IIb 6Class III 18System or Procedure Pack 2

BRBrazilANVISA

47registered devices

Class I 3Class II 44

57 including historic records

SASaudi ArabiaSFDA

0registered imported devices

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

CACanadaMDALL

28active device licences

Class II 26Class III 2

89 including historic records

TWTaiwanTFDA

45valid device licences

Class I 13Class II 32

SGSingaporeHSA SMDR

62device registrations

CLASS B 35CLASS C 9CLASS D 18

KRSouth KoreaMFDS GMP

6GMP quality-system certificates

Import 6

AUAustraliaTGA ARTG

33active ARTG entries

Class I 1Class III 4IIa 18IIb 5Class Is (sterile) 5

HKHong KongMDACS

14valid listings

Class II 7Class III 4Class IV 3

ILIsraelAMAR

12registrations

RURussiaRoszdravnadzor

5active registrations

Class 2a 5

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 Union2,307 raw hits, 0 excluded, 300 confirmed. Large result set — only the first 300 verified

United States217 registration records, 53 510(k), 0 PMA, 3 excluded

United Kingdom54 confirmed, 0 excluded

Brazil47 confirmed, 0 excluded

Canada28 confirmed, 0 excluded

Manufacturer names merged into this page: ARGON MEDICAL DEVICES INC. · ARGON MEDICAL DEVICES, INC. · ARGON MEDICAL DEVICES, INC · ARGON MEDICAL DEVICES INC

Regulatory identity

EU manufacturer SRN: US-MF-000002324
EU authorised representative: Emergo Europe B.V.
UK responsible person: Emergo Consulting (UK) Limited

Business registration

LEI: 549300NEO30N1XPP0580
Registration status: Active
Legal form: Corporation
Incorporated: 2010-03-18
Registered address: C/O COGENCY GLOBAL INC., DOVER, 19904
Registration authority: Division of Corporations, Department of State, no. 4801508
Registry record updated: 2026-02-06

Business registration data from GLEIF, retrieved 2026-09-02. Public registry information only; details of directors and shareholders are not collected.

FDA 510(k) clearances by year

11982

51983

51985

11987

11988

31989

11990

11991

12007

12013

12014

12016

12019

22020

42021

22022

52023

42024

12025

32026

FDA listed device types

showing 8 of 90

Fluorometer, Lead (Dedicated Instruments) 1Peripheral Catheter Insertion Kit 1Needle, Conduction, Anesthetic (W/Wo Introducer) 1Appliance, Fixation, Spinal Intervertebral Body 1Cannula, Catheter 1Trocar 1Injector And Syringe, Angiographic 1Needle, Hypodermic, Single Lumen 1

Registration details (sample)

Market	Identifier	Name	Class / date
EU	20886333004892	Dilator	Class IIa
EU	20886333004885	Dilator	Class IIa
EU	20886333004878	Dilator	Class IIa
EU	00886333217151	Option Elite	Class III
UK	32337	SKATER Drainage Catheter - Centesis	Class IIa
UK	10696	Biliary Drainage Catheter	Class IIb
UK	64326	Biopsy gun handpiece	Class I
US	K252795	ZeniCore Automatic Biopsy Instrument (863212100 / ZeniCore Automatic Biopsy Device 12ga x 10cm with Coaxial Introducer Kit); ZeniCore Automatic Biopsy Instrument (863212130 / ZeniCore Automatic Biopsy Device 12ga x 13cm with Coaxial Introducer Kit); ZeniCore Automatic Biopsy Instrument (863214100 / ZeniCore Automatic Biopsy Device 14ga x 10cm with Coaxial Introducer Kit); ZeniCore Automatic Biopsy Instrument (863214130 / ZeniCore Automatic Biopsy Device 14ga x 13cm with Coaxial	2026-02-23
US	K260028	CLEANER Vac Thrombectomy System, CLEANER Vac Aspiration Catheter with Handpiece, CLEANER Vac Aspiration Canister	2026-02-05
US	K251318	VariFuse Adjustable Infusion Catheter	2026-01-20
BR	10337859017	Kit Introdutor Multipropósito Com Ponta em Curva	Class II
BR	10337850094	Cateter Biliar Skater	Class II
BR	10337850092	Cateter de Nefrostomia Skater	Class II
CA	2064	PROSTATE SEEDING NEEDLE	Class II
CA	5710	BONE MARROW NEEDLES	Class II
CA	5716	THREE PART CALIBRATED COAXIAL CHIBA NEEDLE (MCOCN220866GHN)	Class II