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I-Ming Sanitary Materials Co., Ltd.

Taiwan · Erlin Township Changhua · www.imingbrace.com/en

✓ Record-verifiedregistrations found in 7 marketsEU SRN CN-MF-000036156

This company has registrations in European Union, United States, United Kingdom, Brazil, Saudi Arabia, Australia, Israel — 7 overseas markets. EU UDI-DI records ≥103, 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

≥103UDI-DI device records

Class I 103

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

USUnited StatesFDA openFDA

27listed device types

Class I 23Class II 3Class III 0unclassified 1

plus 26 registration records and 1 510(k)

UKUnited KingdomMHRA PARD

9registered device records

Class I 9

BRBrazilANVISA

3registered devices

Class I 3

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

SASaudi ArabiaSFDA

48registered 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

6active ARTG entries

Class I 6

HKHong KongMDACS

pendingnot queried

ILIsraelAMAR

4registrations

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, 197 excluded, 103 confirmed. Large result set — only the first 300 verified

United States26 registration records, 1 510(k), 0 PMA, 14 excluded

United Kingdom9 confirmed, 4 excluded

Brazil3 confirmed, 1 excluded

Saudi Arabia48 confirmed, 0 excluded

Canada0 confirmed, 3 excluded

Manufacturer names merged into this page: I-MING SANITARY MATERIALS CO., LTD. · MING SANITARY MATERIALS CO. LTD · I-MING SANITARY MATERIAL CO.,LTD. · I-Ming Sanitary Materials Co.Ltd · I-ming sanitary materials co.,ltd. · I-Ming Sanitary Materials Co., Ltd.

Regulatory identity

EU manufacturer SRN: CN-MF-000036156
EU authorised representative: Caretechion GmbH
UK responsible person: UK APLAN CORPORATION LTD

FDA 510(k) clearances by year

12010 · K092892

FDA listed device types

showing 8 of 27

Orthosis, Lumbar 1Splint, Hand, And Components 1Binder, Elastic 1Insoles, Medical 1Support, Hernia 1Splint, Extremity, Noninflatable, External, Sterile 1Orthosis, Limb Brace 1Binder, Abdominal 1

Registration details (sample)

Market	Identifier	Name	Class / date
EU	06949743518783	—	Class I
EU	06949743518752	—	Class I
EU	06949743518745	—	Class I
EU	06949743518738	—	Class I
UK	47217	Abdominal binder	Class I
UK	36206	Ankle / foot orthosis	Class I
UK	12095	Arm immobilizer	Class I
US	K092892	1-M GRADUATED COMPRESSION ANTI-EMBOLISM STOCKING, MODEL SS-811, SS-508, SS-613	2010-08-03
BR	80769660003	Meia de Compressão	Class I
BR	82411060014	Órteses para quadril	Class I
BR	82411060001	Orteses para Coluna	Class I
SA	ME0000005156SFDAA00013	I-M	—
SA	ME0000005156SFDAA00017	I-M	—

I-Ming Sanitary Materials 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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