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Biosystems S.A.

Spain · Barcelona

✓ Record-verifiedregistrations found in 7 markets

This company has registrations in United States, Brazil, Taiwan, Singapore, South Korea, Israel, Russia — 7 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

4510(k) clearances

Class I 0Class II 0Class III 0

plus 0 registration records and 4 510(k)

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

293registered devices

Class I 6Class II 287

303 including historic records

SASaudi ArabiaSFDA

0registered imported devices

low-risk imported devices only; a 2023 snapshot, not updated since

CACanadaMDALL

0active device licences

TWTaiwanTFDA

9valid device licences

Class I 7Class II 2

SGSingaporeHSA SMDR

2device registrations

CLASS B 2

KRSouth KoreaMFDS GMP

1GMP quality-system certificates

IVD import 1

AUAustraliaTGA ARTG

pendingnot queried

HKHong KongMDACS

pendingnot queried

ILIsraelAMAR

1registrations

RURussiaRoszdravnadzor

26active registrations

Class 1 4Class 2a 21Class 2b 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.

United States0 registration records, 4 510(k), 0 PMA, 43 excluded

Brazil293 confirmed, 12 excluded

Saudi Arabia0 confirmed, 1 excluded

Canada0 confirmed, 6 excluded

Manufacturer names merged into this page: BIOSYSTEMS S.A. · BIOSYSTEMS S/A · BIOSYSTEMS S.A

Registration details (sample)

Market	Identifier	Name	Class / date
US	K192730	CALCIUM-CRESOLPHTHALEIN, GLUCOSE, UREA/BUN-UV	2020-09-09
US	K190495	Transferrin	2020-03-16
US	K182474	alpha-AMYLASE DIRECT, alpha-AMYLASE EPS, alpha-AMYLASE PANCREATIC, BILIRUBIN DIRECT, BILIRUBIN TOTAL	2019-05-02
BR	80367750129	Bilirrubina Total e Direta (Reagente AT+AD+BT+BD)	Class II
BR	80367750130	Ferro Ferrozina (Reagente A+B+S)	Class II
BR	80367750131	Família Anti-Estreptolisina O (ASO) (Reagente A+B)	Class II

Biosystems S.A.

Registrations by market

How these numbers were verified

Company information

FDA 510(k) clearances by year

Registration details (sample)

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