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Seirin Corporation

Japan · Shizuoka-Shi · www.seirin.jp

✓ Record-verifiedregistrations found in 9 marketsEU SRN JP-MF-000012274

This company has registrations in European Union, United States, United Kingdom, Canada, Taiwan, Singapore, Australia, Hong Kong, Israel — 9 overseas markets. The China NMPA lookup is still pending.

Registrations by market

Each market counts a different unit; figures are not directly comparable

CNChinaNMPA

n/aThis registry lists domestic registrants only

EUEuropean UnionEUDAMED

166UDI-DI device records

Class IIa 166

USUnited StatesFDA openFDA

3listed device types

Class I 2Class II 1Class III 0

plus 3 registration records and 0 510(k)

UKUnited KingdomMHRA PARD

2registered device records

Class I 1Class IIa 1

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

1 including historic records

TWTaiwanTFDA

1valid device licences

Class II 1

SGSingaporeHSA SMDR

3device registrations

CLASS B 3

KRSouth KoreaMFDS GMP

pendingnot queried

AUAustraliaTGA ARTG

3active ARTG entries

Class I 2IIa 1

HKHong KongMDACS

2valid listings

Class II 2

ILIsraelAMAR

3registrations

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 Union166 raw hits, 0 excluded, 166 confirmed

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

United Kingdom2 confirmed, 0 excluded

Canada0 confirmed, 1 excluded

Manufacturer names merged into this page: SEIRIN CORPORATION

Regulatory identity

EU manufacturer SRN: JP-MF-000012274
EU authorised representative: Emergo Europe B.V.
UK responsible person: Atlantic Bridge Limited

Registration details (sample)

Market	Identifier	Name	Class / date
EU	04547248110390	SEIRIN Acupuncture Needles	Class IIa
EU	04547248210502	SEIRIN Acupuncture Needles	Class IIa
EU	04547248210489	SEIRIN Acupuncture Needles	Class IIa
EU	04547248210496	SEIRIN Acupuncture Needles	Class IIa
UK	34175	SEIRIN Acupuncture Needles	Class IIa
UK	45167	Moxa	Class I

Seirin Corporation

Registrations by market

How these numbers were verified

Regulatory identity

Company information

FDA listed device types

Registration details (sample)

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