BSL Co., Ltd.

Korea, Republic · Busan

✓ Record-verifiedregistrations found in 4 markets

This company has registrations in United States, Brazil, Singapore, Australia — 4 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

pendingnot queried

USUnited StatesFDA openFDA

4listed device types

Class I 3Class II 1Class III 0

plus 5 registration records and 2 510(k)

UKUnited KingdomMHRA PARD

pendingnot queried

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

0active device licences

TWTaiwanTFDA

pendingnot queried

SGSingaporeHSA SMDR

1device registrations

CLASS B 1

KRSouth KoreaMFDS GMP

pendingnot queried

AUAustraliaTGA ARTG

3active ARTG entries

Class I 2IIa 1

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.

United States5 registration records, 2 510(k), 0 PMA

Brazil3 confirmed, 0 excluded

Manufacturer names merged into this page: BSL Co., Ltd. · BSL CO., LTD

FDA 510(k) clearances by year

12018 · K172717

12021 · K202443

FDA listed device types

Centrifuges (Micro, Ultra, Refrigerated) For Clinical Use 1Instrument, Manual, Surgical, General Use 1Container, Specimen Mailer And Storage, Temperature Controlled, Non-Sterile 1Lipoaspirate Washing System For Aesthetic Body Contouring 1

Registration details (sample)

Market	Identifier	Name	Class / date
US	K202443	Smart Kit Basic, Smart Kit Pro	2021-03-11
US	K172717	Automatic Tissue Processing Unit	2018-05-25
BR	82727399016	Adinizer Smart Kit	Class II
BR	82727399017	Adinizer Smart Kit Pro	Class II
BR	82727399021	Adinizer Smart Kit Exomn	Class II

BSL Co., Ltd.

Registrations by market

How these numbers were verified

Company information

FDA 510(k) clearances by year

FDA listed device types

Registration details (sample)

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