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Changzhou Care-de Sanitary Material Co., Ltd.

China · Changzhou Jiangsu · www.care-de.com

✓ Record-verifiedregistrations found in 4 marketsEU SRN CN-MF-000013051

This company has registrations in European Union, United States, United Kingdom, Saudi Arabia — 4 overseas markets. EU UDI-DI records ≥62, 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

≥62UDI-DI device records

Class I 62

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

USUnited StatesFDA openFDA

10listed device types

Class I 10Class II 0Class III 0

plus 10 registration records and 0 510(k)

UKUnited KingdomMHRA PARD

4registered device records

Class I 4

BRBrazilANVISA

0registered devices

this export covers Class I / II only (the cadastro route)

SASaudi ArabiaSFDA

1registered 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 Union757 raw hits, 238 excluded, 62 confirmed. Large result set — only the first 300 verified

United States10 registration records, 0 510(k), 0 PMA, 44 excluded

United Kingdom4 confirmed, 4 excluded

Brazil0 confirmed, 8 excluded

Saudi Arabia1 confirmed, 15 excluded

Canada0 confirmed, 1 excluded

Manufacturer names merged into this page: CHANGZHOU CARE-DE SANITARY MATERIAL CO., LTD · CHANGZHOU CARE-DE SANITARY MATERIAL CO.,LTD

Regulatory identity

EU manufacturer SRN: CN-MF-000013051
EU authorised representative: Caretechion GmbH
UK responsible person: SUNGO Certification Company Limited

FDA listed device types

showing 8 of 10

Absorber, Saliva, Paper 1Garment, Protective, For Incontinence 1Cover, Mattress (Medical Purposes) 1Gown, Examination 1Non-Surgical Gown 1Dressing, Wound, Hydrophilic 1Tape And Bandage, Adhesive 1Mouthpiece, Saliva Ejector 1

Registration details (sample)

Market	Identifier	Name	Class / date
EU	06971519617406	sterile first aid bandage	Class I
EU	06971519617390	sterile first aid bandage	Class I
EU	16971519615485	STERILE FIRST AID BANDAGE	Class I
EU	16971519615478	STERILE FIRST AID BANDAGE	Class I
UK	16866	surgical tapes	Class I
UK	47011	Sterile First Aid Bandage	Class I
UK	58964	Bandage	Class I
SA	ME0000000531SFDAA00011	Pad	—

Changzhou Care-de Sanitary Material 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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