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Epic International (Thailand) Co., Ltd.

Thailand · Amphur Pluakdaeng

✓ Record-verifiedregistrations found in 7 markets

This company has registrations in United States, Brazil, Canada, Singapore, South Korea, Australia, Israel — 7 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 1Class II 6Class III 0

plus 23 registration records and 0 510(k)

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

6registered devices

Class I 2Class II 4

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

10 including historic records

TWTaiwanTFDA

pendingnot queried

SGSingaporeHSA SMDR

3device registrations

CLASS B 1CLASS C 2

KRSouth KoreaMFDS GMP

1GMP quality-system certificates

Import 1

AUAustraliaTGA ARTG

18active ARTG entries

IIa 4IIb 5Class Is (sterile) 9

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 States23 registration records, 0 510(k), 0 PMA, 8 excluded

Brazil6 confirmed, 0 excluded

Canada0 confirmed, 2 excluded

Manufacturer names merged into this page: Epic International (Thailand) Co., Ltd. · EPIC INTERNATIONAL (THAILAND) CO., LTD. · EPIC INTERNATIONAL THAILAND CO., LTD

FDA listed device types

Pump, Infusion, Elastomeric 1Set, I.V. Fluid Transfer 1System/Device, Pharmacy Compounding 1Set, Administration, Intravascular 1Closed Antineoplastic And Hazardous Drug Reconstitution And Transfer System 1Container, I.V. 1Dispenser, Liquid Medication 1

Registration details (sample)

Market	Identifier	Name	Class / date
BR	81375039002	Bomba de Infusão Elastomérica SMARTeZ® RS ChemoSafe	Class II
BR	81375030022	ToxiSeal- Adaptador para Frasco com Balão Externo	Class I
BR	81375030023	ProSeal Injector / ProSeal Injector Plus	Class I

Epic International (Thailand) Co., Ltd.

Registrations by market

How these numbers were verified

Company information

FDA listed device types

Registration details (sample)

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