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TSK Laboratory, Japan CO., LTD

Japan · Tochigi-Shi Tochigi-Ken · www.tsklab.co.jp

✓ Record-verifiedregistrations found in 12 marketsEU SRN JP-MF-000008485

This company has registrations in European Union, United States, United Kingdom, Brazil, Canada, Taiwan, Singapore, South Korea, Australia, Hong Kong, Israel, Russia — 12 overseas markets. EU UDI-DI records ≥300, 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

n/aThis registry lists domestic registrants only

EUEuropean UnionEUDAMED

≥300UDI-DI device records

Class I 2Class IIa 298

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

USUnited StatesFDA openFDA

5listed device types

Class I 1Class II 3Class III 0unclassified 1

plus 7 registration records and 5 510(k)

UKUnited KingdomMHRA PARD

12registered device records

Class I 1Class IIa 11

BRBrazilANVISA

5registered devices

Class II 5

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

1active device licences

Class II 1

17 including historic records

TWTaiwanTFDA

5valid device licences

Class II 5

SGSingaporeHSA SMDR

11device registrations

CLASS B 11

KRSouth KoreaMFDS GMP

1GMP quality-system certificates

Import 1

AUAustraliaTGA ARTG

9active ARTG entries

IIa 8Class Is (sterile) 1

HKHong KongMDACS

5valid listings

Class II 5

ILIsraelAMAR

9registrations

RURussiaRoszdravnadzor

1active registrations

Class 2a 1

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 Union458 raw hits, 0 excluded, 300 confirmed. Large result set — only the first 300 verified

United States7 registration records, 5 510(k), 0 PMA, 1 excluded

United Kingdom12 confirmed, 0 excluded

Brazil5 confirmed, 0 excluded

Canada1 confirmed, 1 excluded

Manufacturer names merged into this page: TSK Laboratory International Japan KK · TSK LABORATORY, JAPAN · TSK LABORATORY INTERNATIONAL JAPAN · TSK - LABORATORY · TSK LABORATORY JAPAN

Regulatory identity

EU manufacturer SRN: JP-MF-000008485
EU authorised representative: Emergo Europe B.V.
UK responsible person: Emergo Consulting (UK) Limited

Registration details (sample)

Market	Identifier	Name	Class / date
EU	04580708068381	TSK Co-axial Guide Needle	Class IIa
EU	04580708068480	TSK Co-axial Guide Needle	Class IIa
EU	04580708068503	TSK Co-axial Guide Needle	Class IIa
EU	04580708068497	TSK Co-axial Guide Needle	Class IIa
UK	46350	TSK BONE MARROW BIOPSY SYSTEM	Class IIa
UK	46350	TSK BMB	Class IIa
UK	47017	TSK Syringe	Class I
US	K250127	TSK Syringe	2025-07-30
US	K250284	TSK SELECT Needle	2025-07-24
US	K242073	STERiJECT Ophthalmic Needle; STERiJECT Ophthalmic Needle Low Dead Space (LDS)	2024-10-23
BR	10408000001	AGULHA PARA BIOPSIA ACECUT	Class II
BR	81346500001	Cânula Descartável Premium STERIGLIDE	Class II
BR	81346500002	Cânula Descartável Premium Steriject - CSH	Class II
CA	89527	DENTAL NEEDLES	Class II

TSK Laboratory, Japan 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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