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Copioumed International Inc.

Taiwan · Taipei City · www.copioumed-tw.com

✓ Record-verifiedregistrations found in 3 marketsEU SRN TW-MF-000011340

This company has registrations in European Union, United States, Australia — 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

pendingnot queried

EUEuropean UnionEUDAMED

52UDI-DI device records

Class I 52

USUnited StatesFDA openFDA

14listed device types

Class I 10Class II 4Class III 0

plus 29 registration records and 2 510(k)

UKUnited KingdomMHRA PARD

0registered device records

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

pendingnot queried

AUAustraliaTGA ARTG

2active ARTG entries

Class I 2

HKHong KongMDACS

pendingnot queried

ILIsraelAMAR

pendingnot queried

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.

European Union52 raw hits, 0 excluded, 52 confirmed

United States29 registration records, 2 510(k), 0 PMA, 1 excluded

Manufacturer names merged into this page: COPIOUMED INTERNATIONAL, INC.

Regulatory identity

EU manufacturer SRN: TW-MF-000011340
EU authorised representative: MedNet EC-REP GmbH

FDA 510(k) clearances by year

12023 · K230135

12026 · K251860

FDA listed device types

showing 8 of 14

Gown, Surgical 1Mask, Surgical 1Gown, Isolation, Surgical 1Medical Gowns With Chemotherapy Labeling Claims - Tested For Use With Chemotherapy Drugs 1Cap, Surgical 1Accessory, Surgical Apparel 1Garment, Protective, For Incontinence 1Gown, Examination 1

Registration details (sample)

Market	Identifier	Name	Class / date
EU	04719882252730	Copioumed Headwear, Blue, Surgical Cap	Class I
EU	04719882252716	Copioumed Headwear, Blue, Surgical Cap	Class I
EU	04719882252693	Copioumed Headwear, Blue, Surgical Cap	Class I
EU	04719882252679	Copioumed Headwear, Blue, Surgical Cap	Class I
US	K251860	Copioumed AAMI 3 Surgical Gown	2026-02-26
US	K230135	Copioumed Chemotherapy Isolation Gown	2023-10-04

Copioumed International Inc.

Registrations by market

How these numbers were verified

Regulatory identity

Company information

FDA 510(k) clearances by year

FDA listed device types

Registration details (sample)

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