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SB-KAWASUMI LABORATORIES, INC.

✓ Record-verifiedregistrations found in 9 marketsEU SRN JP-MF-000011253

This company has registrations in European Union, United States, United Kingdom, Brazil, Canada, Taiwan, Singapore, Australia, Russia — 9 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 IIa 289Class IIb 5Class III 6

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

USUnited StatesFDA openFDA

34510(k) clearances

Class I 0Class II 0Class III 0

plus 0 registration records and 34 510(k)

UKUnited KingdomMHRA PARD

1registered device records

Class IIb 1

BRBrazilANVISA

3registered devices

Class II 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

2active device licences

Class II 2

10 including historic records

TWTaiwanTFDA

1valid device licences

Class I 1

SGSingaporeHSA SMDR

7device registrations

CLASS B 6CLASS C 1

KRSouth KoreaMFDS GMP

pendingnot queried

AUAustraliaTGA ARTG

2active ARTG entries

IIa 1IIb 1

HKHong KongMDACS

pendingnot queried

ILIsraelAMAR

pendingnot queried

RURussiaRoszdravnadzor

4active registrations

Class 2a 1Class 2b 3

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 Union553 raw hits, 0 excluded, 300 confirmed. Large result set — only the first 300 verified

United States0 registration records, 34 510(k), 0 PMA, 3 excluded

United Kingdom1 confirmed, 0 excluded

Brazil3 confirmed, 1 excluded

Canada2 confirmed, 0 excluded

Manufacturer names merged into this page: KAWASUMI LABORATORIES INC. · SB-KAWASUMI LABORATORIES, INC

Regulatory identity

EU manufacturer SRN: JP-MF-000011253
EU authorised representative: MPS Medical Product Service GmbH
UK responsible person: MT Promedt Consulting Ltd
Exhibition record: CMEF 87th (Spring 2023, Shanghai)

Registration details (sample)

Market	Identifier	Name	Class / date
EU	04987488107666	Najuta Thoracic Stent Graft System	Class III
EU	04987488107659	Najuta Thoracic Stent Graft System	Class III
EU	04987488107635	Najuta Thoracic Stent Graft System	Class III
EU	04987488107611	Najuta Thoracic Stent Graft System	Class III
UK	60915	Plasma Component Separator Cascadeflo EC	Class IIb
US	K252355	K-SHIELD Advantage PORT ACCESS INFUSION SET With High Pressure Tubing	2025-11-26
US	K241855	SB Knife Jr2 (MD-47702 and MD-47702L)	2025-03-26
US	K230408	K-SHIELD Zen (Model Numbers: PBMH/ PBMA/ PBM)	2023-06-01
BR	10234400138	Agulha para acesso a cateter totalmente implantável tipo Hubber - K-Sh	Class II
BR	10234400139	Agulha para acesso a cateter totalmente implantável tipo Hubber - K-Sh	Class II
BR	10234400133	Agulha para aceso a cateter totalmente implantável tipo Hubber	Class II
CA	66629	BLOOD DRAWING KIT	Class II
CA	66635	PHLEBOTOMY SET	Class II

SB-KAWASUMI LABORATORIES, INC.

Registrations by market

How these numbers were verified

Regulatory identity

Company information

FDA 510(k) clearances by year

Registration details (sample)

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