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ATRION MEDICAL PRODUCTS, INC.

USA · Arab

✓ Record-verifiedregistrations found in 8 markets

This company has registrations in United States, Brazil, Canada, Taiwan, South Korea, Australia, Israel, Russia — 8 overseas markets. 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

pendingnot queried

USUnited StatesFDA openFDA

11listed device types

Class I 2Class II 9Class III 0

plus 14 registration records and 9 510(k), 11 PMA

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

7registered devices

Class I 5Class II 2

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

6 including historic records

TWTaiwanTFDA

1valid device licences

Class II 1

SGSingaporeHSA SMDR

pendingnot queried

KRSouth KoreaMFDS GMP

2GMP quality-system certificates

Import 2

AUAustraliaTGA ARTG

11active ARTG entries

Class Is (sterile) 11

HKHong KongMDACS

pendingnot queried

ILIsraelAMAR

8registrations

RURussiaRoszdravnadzor

1active registrations

Class 2a 1

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.

United States14 registration records, 9 510(k), 11 PMA

Brazil7 confirmed, 0 excluded

Manufacturer names merged into this page: ATRION MEDICAL PRODUCTS, INC. · ATRION MEDICAL PRODUCTS INC. · ATRION MEDICAL PRODUCTS INC

FDA 510(k) clearances by year

21997 · K972964

21998 · K973633

12002 · K020333

22004 · K041158

12005 · K043249

12006 · K060643

FDA listed device types

showing 8 of 11

Dilator, Lachrymal 1Instrument, Ent Manual Surgical 1Anesthesia Conduction Kit 1Syringe, Balloon Inflation 1Dilator, Urethral 1Injector And Syringe, Angiographic 1Needle, Hypodermic, Single Lumen 1Syringe, Balloon Inflation, Exempt 1

Registration details (sample)

Market	Identifier	Name	Class / date
US	K060643	QL LOCKING SYRINGE	2006-07-12
US	K043249	ATRION NEEDLEVISE LARGE-BORE SHARPS SECURING DEVICE	2005-05-25
US	K041158	ATRION EPIDURAL ANESTHESIA KIT WITH ATRION NEEDLEVISE SHARPS SECURING SYSTEM	2004-06-16
BR	10341351056	Encore 40 Dispositivo de Insuflação	Class I
BR	80898209014	QL® Inflation Device Balloon Catheter Dilation	Class II
BR	10212990147	INSUFLADOR	Class II

ATRION MEDICAL PRODUCTS, INC.

Registrations by market

How these numbers were verified

Company information

FDA 510(k) clearances by year

FDA listed device types

Registration details (sample)

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