HomeUSAEpimed International, Inc.

Epimed International, Inc.

USA · Johnstown
✓ Record-verifiedregistrations found in 9 markets

This company has registrations in United States, Brazil, Canada, Taiwan, Singapore, South Korea, Australia, Hong Kong, Israel — 9 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 40 registration records and 16 510(k)
UKUnited KingdomMHRA PARD
pendingnot queried
BRBrazilANVISA
13registered devices
Class I 1Class II 12
17 including historic records
SASaudi ArabiaSFDA
0registered imported devices
low-risk imported devices only; a 2023 snapshot, not updated since
CACanadaMDALL
0active device licences
9 including historic records
TWTaiwanTFDA
3valid device licences
Class II 3
SGSingaporeHSA SMDR
12device registrations
CLASS B 12
KRSouth KoreaMFDS GMP
1GMP quality-system certificates
Import 1
AUAustraliaTGA ARTG
4active ARTG entries
IIa 2IIb 2
HKHong KongMDACS
3valid listings
Class II 3
ILIsraelAMAR
2registrations
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 States40 registration records, 16 510(k), 0 PMA
Brazil13 confirmed, 2 excluded
Manufacturer names merged into this page: Epimed International, Inc. · EPIMED INTERNATIONAL, INC. · EPIMED INTERNATIONAL INC. · EPIMED INTERNATIONAL, INC

Company information

Country
USA
City
Johnstown

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

11998
22002
22003
22004
32005
12006
12008
12014
12019
12020
12024

FDA listed device types

showing 8 of 11
Catheter, Conduction, Anesthetic 1Probe, Radiofrequency Lesion 1Needle, Conduction, Anesthetic (W/Wo Introducer) 1Anesthesia Conduction Kit 1Marker, Cardiopulmonary Bypass (Vein Marker) 1Set, Administration, Intravascular 1Needle, Spinal, Short Term 1Device, Surgical, Cryogenic 1

Registration details (sample)

MarketIdentifierNameClass / date
USK232632Racz Neurostat RF Generator2024-05-24
USK200624Percutaneous Introducer2020-04-27
USK190256Rulo Radiofrequency Lesion Probe2019-03-08
BR81050760045Cânula de Bloqueio Direcionavel com Ponta Atraumática.Class II
BR81050760058Cânula Cobra RF com saída lateral para injeção de fármacosClass II
BR81050760034Probe para Cânula para Radiofreqüência em Nitinol EpimedClass II

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