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Danyang Sunmed Healthcare Corp.

China · Danyang Jiangsu · www.chinasunmed.com

✓ Record-verifiedregistrations found in 5 marketsEU SRN CN-MF-000013734

This company has registrations in European Union, United States, United Kingdom, Brazil, Australia — 5 overseas markets. EU UDI-DI records ≥15, 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

≥15UDI-DI device records

Class I 15

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 9Class II 1Class III 0

plus 10 registration records and 0 510(k)

UKUnited KingdomMHRA PARD

12registered device records

Class I 12

BRBrazilANVISA

3registered devices

Class I 3

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 Is (sterile) 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 Union2,170 raw hits, 285 excluded, 15 confirmed. Large result set — only the first 300 verified

United States10 registration records, 0 510(k), 0 PMA, 9 excluded

United Kingdom12 confirmed, 4 excluded

Brazil3 confirmed, 3 excluded

Saudi Arabia0 confirmed, 6 excluded

Canada0 confirmed, 3 excluded

Manufacturer names merged into this page: DANYANG SUNMED HEALTHCARE CORPORATION

Regulatory identity

EU manufacturer SRN: CN-MF-000013734
EU authorised representative: Shanghai International Holding Corp. GmbH(Europe)
UK responsible person: Etheria Medical Ltd

FDA listed device types

showing 8 of 10

Accessory, Surgical Apparel 1Disinfectant, Medical Devices 1Pack, Hot Or Cold, Disposable 1First Aid Kit Without Drug 1Toothbrush, Manual 1Pack, Hot Or Cold, Reusable 1Components, Wheelchair 1Tape And Bandage, Adhesive 1

Registration details (sample)

Market	Identifier	Name	Class / date
EU	05404050401728	Adhesive tape refill	Class I
EU	05404050401711	Surgical tape	Class I
EU	05404050401704	Surgical tape	Class I
EU	05404050401698	Finger plasters	Class I
UK	34864	Sterile Hemostasis Adhesive Dressing	Class I
UK	61326	CPR mask (Respiration; safe kiss)	Class I
UK	16866	Surgical Tape	Class I
BR	80228410064	BANDAGEM	Class I
BR	10332820038	ESPARADRAPO IMPERMEAVEL CIEX	Class I
BR	10332829024	k-muscle tape ciex do brasil - bandagem adesiva elástica Kinesiology t	Class I

Danyang Sunmed Healthcare Corp.

Registrations by market

How these numbers were verified

Regulatory identity

Company information

FDA listed device types

Registration details (sample)

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