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Changzhou Hongtai Paper Film Co., Ltd.

China · Changzhou Jiangsu · www.cnhtzm.com

✓ Record-verifiedregistrations found in 4 marketsEU SRN CN-MF-000003240

This company has registrations in European Union, United States, United Kingdom, Australia — 4 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

14UDI-DI device records

Class I 14

USUnited StatesFDA openFDA

9listed device types

Class I 8Class II 0Class III 0unclassified 1

plus 9 registration records and 0 510(k)

UKUnited KingdomMHRA PARD

3registered device records

Class I 3

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

1active ARTG entries

Class I 1

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 Union128 raw hits, 114 excluded, 14 confirmed

United States9 registration records, 0 510(k), 0 PMA, 4 excluded

United Kingdom3 confirmed, 0 excluded

Manufacturer names merged into this page: CHANGZHOU HONGTAI PAPER FILM CO., LTD

Regulatory identity

EU manufacturer SRN: CN-MF-000003240
EU authorised representative: SUNGO Europe B.V.
UK responsible person: SUNGO Certification Company Limited

FDA listed device types

showing 8 of 9

Absorber, Saliva, Paper 1Garment, Protective, For Incontinence 1Cover, Mattress (Medical Purposes) 1Gown, Examination 1Non-Surgical Gown 1Applicator, Absorbent Tipped, Sterile 1Mouthpiece, Saliva Ejector 1Bedding, Disposable, Medical 1

Registration details (sample)

Market	Identifier	Name	Class / date
EU	06972952000251	Disposable Bed Sheet	Class I
EU	06972952000039	Disposable Underpads	Class I
EU	06972952001029	Disposable Underpads	Class I
EU	06972952000053	Disposable Underpads	Class I
UK	61850	Disposable Underpads	Class I
UK	11239	Adult Diaper	Class I
UK	35880	Couch Paper Rolls	Class I

Changzhou Hongtai Paper Film Co., Ltd.

Registrations by market

How these numbers were verified

Regulatory identity

Company information

FDA listed device types

Registration details (sample)

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