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Atrium Medical Corporation

USA · Merrimack

✓ Record-verifiedregistrations found in 11 markets

This company has registrations in United States, Brazil, Saudi Arabia, Canada, Taiwan, Singapore, South Korea, Australia, Hong Kong, Israel, Russia — 11 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

9listed device types

Class I 3Class II 5Class III 1

plus 13 registration records and 69 510(k), 12 PMA

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

6registered devices

Class I 2Class II 4

17 including historic records

SASaudi ArabiaSFDA

1registered imported devices

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

CACanadaMDALL

6active device licences

Class II 1Class III 2Class IV 3

19 including historic records

TWTaiwanTFDA

5valid device licences

Class I 2Class II 2Class III 1

SGSingaporeHSA SMDR

3device registrations

CLASS D 3

KRSouth KoreaMFDS GMP

1GMP quality-system certificates

Import 1

AUAustraliaTGA ARTG

5active ARTG entries

Class I 1Class III 2IIb 1Class Is (sterile) 1

HKHong KongMDACS

3valid listings

Class IV 3

ILIsraelAMAR

6registrations

RURussiaRoszdravnadzor

5active registrations

Class 2a 1Class 3 4

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 States13 registration records, 69 510(k), 12 PMA

Brazil6 confirmed, 0 excluded

Saudi Arabia1 confirmed, 0 excluded

Canada6 confirmed, 0 excluded

Manufacturer names merged into this page: Atrium Medical Corporation · ATRIUM MEDICAL CORPORATION

FDA 510(k) clearances by year

11994

11995

11997

71999

42000

32001

32002

22004

32005

42006

22007

32008

22009

32010

22011

22012

22013

22015

12021

12024

FDA listed device types

showing 8 of 9

Prosthesis, Vascular Graft, Of Less Then 6mm Diameter 1Bottle, Collection, Vacuum 1Prosthesis, Tracheal, Expandable 1Apparatus, Autotransfusion 1Prosthesis, Vascular Graft, Of 6mm And Greater Diameter 1Accessories, Catheter 1Instruments, Surgical, Cardiovascular 1Catheter, Cholangiography 1

Registration details (sample)

Market	Identifier	Name	Class / date
US	K231972	Advanta VXT Vascular Graft, Flixene Vascular Graft	2024-03-28
US	K201305	Auto transfusion (ATS) Chest Drains: Ocean Water Seal Chest Drain, Oasis Dry Suction Water Seal Chest Drain, Express Dry Seal Chest Drain	2021-09-03
US	K151386	C-QUR, C-QUR FX, C-QUR TacShield, C-QUR V-Patch, C-QUR CentriFX, C-QUR Mosaic	2015-10-22
BR	80259110168	Conjunto de Tunelizadores Atrium	Class I
BR	80259110170	Tunelizador Atrium	Class I
BR	80259110190	Drenagem Torácica com Selo Seco Express Mini	Class II
SA	ME0000003543SFDAA00010	Vascular Graft Tunneler Instrumentation	—
CA	28568	ULTRAMAX DOUBLE VELOUR VASCULAR GRAFT	Class IV
CA	30232	ATRIUM FACIAL IMPLANTS	Class III
CA	34947	ADVANTA SUPER SOFT PTFE VASCULAR GRAFT	Class IV