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Home›USA›ACCESS POINT TECHNOLOGIES, EP INC.

ACCESS POINT TECHNOLOGIES, EP INC.

USA · Rogers
✓ Record-verifiedregistrations found in 4 markets

This company has registrations in United States, South Korea, Israel, Russia — 4 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
3listed device types
Class I 0Class II 2Class III 1
plus 4 registration records and 16 510(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
pendingnot queried
SGSingaporeHSA SMDR
pendingnot queried
KRSouth KoreaMFDS GMP
1GMP quality-system certificates
Import 1
AUAustraliaTGA ARTG
pendingnot queried
HKHong KongMDACS
pendingnot queried
ILIsraelAMAR
2registrations
RURussiaRoszdravnadzor
1active registrations
Class 2b 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 States4 registration records, 16 510(k), 0 PMA, 9 excluded
Brazil0 confirmed, 2 excluded
Saudi Arabia0 confirmed, 1 excluded
Manufacturer names merged into this page: ACCESS POINT TECHNOLOGIES, EP INC.
Same-named companies — This database also contains companies with near-identical names: Ep Technologies, Inc.. Company name alone cannot separate their registrations, so the figures below may include either.

Company information

Country
USA
City
Rogers

Fields marked "pending" have not been obtained yet; that does not mean they do not exist. Risk records (litigation, penalties, operating anomalies) are kept internal and not published.

FDA 510(k) clearances by year

11988
21989
41990
11991
21993
21994
12000
12002
12005
12016

FDA listed device types

Catheter, Electrode Recording, Or Probe, Electrode Recording 1Cable, Electrode 1Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Fibrillation 1

Registration details (sample)

MarketIdentifierNameClass / date
USK160390Map-it Diagnostic Mapping Catheters2016-04-11
USK043257REAL-TIME POSITION MANAGEMENT (RPM) SYSTEM2005-02-03
USK013349ASTRONOMER PLUS SYSTEM2002-04-09

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