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Access Point Medical, LLC

USA · Potomac

✓ Record-verifiedregistrations found in 3 markets

This company has registrations in United States, South Korea, Israel — 3 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

7listed device types

Class I 0Class II 6Class III 1

plus 8 registration records and 5 510(k)

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

0registered devices

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

TWTaiwanTFDA

0valid device licences

SGSingaporeHSA SMDR

pendingnot queried

KRSouth KoreaMFDS GMP

1GMP quality-system certificates

Manufacturing 1

AUAustraliaTGA ARTG

pendingnot queried

HKHong KongMDACS

pendingnot queried

ILIsraelAMAR

1registrations

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.

United States8 registration records, 5 510(k), 0 PMA, 27 excluded

Brazil0 confirmed, 5 excluded

Saudi Arabia0 confirmed, 1 excluded

Canada0 confirmed, 3 excluded

Manufacturer names merged into this page: POINT MEDICAL CORP. · ACCESS POINT TECHNOLOGIES, EP INC.

FDA 510(k) clearances by year

32005 · K050280

12007 · K063449

12016 · K160390

FDA listed device types

Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days 1Cable, Electrode 1Catheter, Subclavian 1Catheter, Peritoneal, Long-Term Indwelling 1Catheter, Electrode Recording, Or Probe, Electrode Recording 1Catheter, Hemodialysis, Implanted 1Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Fibrillation 1

Market	Identifier	Name	Class / date
US	K160390	Map-it Diagnostic Mapping Catheters	2016-04-11
US	K063449	DELUXE NEBULIZER	2007-03-01
US	K050280	RUNABOUT WHEELCHAIR	2005-04-11

Access Point Medical, LLC

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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