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Suzhou Healthline Medical Co.,Ltd.

China · Suzhou Jiangsu · www.healthline-medical.com

✓ Record-verifiedregistrations found in 3 marketsEU SRN CN-MF-000033568

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

34UDI-DI device records

Class I 34

USUnited StatesFDA openFDA

3listed device types

Class I 3Class II 0Class III 0

plus 3 registration records and 1 510(k)

UKUnited KingdomMHRA PARD

0registered device records

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

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 Union253 raw hits, 219 excluded, 34 confirmed

United States3 registration records, 1 510(k), 0 PMA, 3 excluded

United Kingdom0 confirmed, 2 excluded

Brazil1 confirmed, 0 excluded

Canada0 confirmed, 1 excluded

Manufacturer names merged into this page: SUZHOU HEALTHLINE MEDICAL CO.,LTD. · SUZHOU HEALTHLINE MEDICAL CO., LTD

Regulatory identity

EU manufacturer SRN: CN-MF-000033568
EU authorised representative: SUNGO Europe B.V.

Registration details (sample)

Market	Identifier	Name	Class / date
EU	06975976510515	KENDiNDEN YAPISKANLI ELASTiK BANDAJ	Class I
EU	06975976511048	JENBOL Kinesiyoloji Bandı	Class I
EU	06975976510423	JENBOL Kinesiyoloji Bandı	Class I
EU	06975976510447	JENBOL Kinesiyoloji Bandı	Class I
US	K960397	MEDICATOR AEROSOL DRUG DELIVERY SYSTEM	1996-04-26
BR	80153030181	KINESIOtape, Bandagem Cinesiológica	Class I

Suzhou Healthline Medical 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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