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Changzhou Standard Medical Devices Co.,Ltd.

China · Changzhou Jiangsu · www.standard-med.com

✓ Record-verifiedregistrations found in 5 marketsEU SRN CN-MF-000018989

This company has registrations in European Union, United States, United Kingdom, Brazil, Israel — 5 overseas markets. EU UDI-DI records ≥2, the first 300 verified individually. 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

≥2UDI-DI device records

Class I 2

large result set — only the first 300 records were verified, so the real figure is at least this

USUnited StatesFDA openFDA

1listed device types

Class I 0Class II 1Class III 0

plus 3 registration records and 3 510(k)

UKUnited KingdomMHRA PARD

2registered device records

Class IIb 2

BRBrazilANVISA

1registered devices

Class I 1

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

pendingnot queried

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.

European Union1,295 raw hits, 298 excluded, 2 confirmed. Large result set — only the first 300 verified

United States3 registration records, 3 510(k), 0 PMA, 27 excluded

United Kingdom2 confirmed, 3 excluded

Brazil1 confirmed, 7 excluded

Saudi Arabia0 confirmed, 1 excluded

Canada0 confirmed, 5 excluded

Manufacturer names merged into this page: MEDICAL STANDARD CO., LTD. · CHANGZHOU STANDARD MEDICAL DEVICES CO., LTD.

Regulatory identity

EU manufacturer SRN: CN-MF-000018989
EU authorised representative: MedPath GmbH
UK responsible person: Omnimed Limited

Registration details (sample)

Market	Identifier	Name	Class / date
EU	06971693156692	Urine Drainage Bag	Class I
EU	06971693156623	Urine Drainage Bag	Class I
UK	62217	The Standard Co Ltd	Class IIb
UK	17828	The Standard Co Ltd	Class IIb
US	K083658	PACS PLUS 5TH EDITION	2009-07-07
US	K042311	PACSPARTNER	2004-09-09
US	K023460	PACSPLUS	2003-01-09
BR	10160610142	BOLSA COLETORA DE URINA - INJEX	Class I

Changzhou Standard Medical Devices Co.,Ltd.

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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