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Sterileright Packaging Mfg Inc.

Taiwan · Keelung · www.sterileright.com.tw

✓ Record-verifiedregistrations found in 3 marketsEU SRN TW-MF-000016422

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

68UDI-DI device records

Class I 68

USUnited StatesFDA openFDA

2listed device types

Class I 0Class II 2Class III 0

plus 1 registration records and 1 510(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 Union68 raw hits, 0 excluded, 68 confirmed

United States1 registration records, 1 510(k), 0 PMA

Manufacturer names merged into this page: STERILERIGHT PACKAGING MFG INC.

Regulatory identity

EU manufacturer SRN: TW-MF-000016422
EU authorised representative: CMC Medical Devices & Drugs SL

Registration details (sample)

Market	Identifier	Name	Class / date
EU	05902340984239	MEDIROLL 400MM X 100M	Class I
EU	05902340984222	MEDIROLL 350MM X 100M	Class I
EU	05902340984215	MEDIROLL 300MM X 100M	Class I
EU	05902340984208	MEDIROLL 250MM X 100M	Class I
US	K212338	SterileRight sterilization pouch and roll	2021-11-01

Sterileright Packaging Mfg 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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