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Biokit, S.A.

Spain · Lliçà D'Amunt

✓ Record-verifiedregistrations found in 10 markets

This company has registrations in United States, Brazil, Canada, Taiwan, Singapore, South Korea, Australia, Hong Kong, Israel, Russia — 10 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

40listed device types

Class I 12Class II 28Class III 0

plus 58 registration records and 39 510(k)

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

25registered devices

Class I 2Class II 23

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

19active device licences

Class II 18Class III 1

47 including historic records

TWTaiwanTFDA

55valid device licences

Class I 9Class II 46

SGSingaporeHSA SMDR

21device registrations

CLASS B 17CLASS C 4

KRSouth KoreaMFDS GMP

8GMP quality-system certificates

IVD import 8

AUAustraliaTGA ARTG

16active ARTG entries

IVD Class 1 2IVD Class 2 10IVD Class 3 4

HKHong KongMDACS

6valid listings

IVD B 6

ILIsraelAMAR

10registrations

RURussiaRoszdravnadzor

20active registrations

Class 1 1Class 2a 17Class 2b 1Class 3 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 States58 registration records, 39 510(k), 0 PMA

Brazil25 confirmed, 1 excluded

Canada19 confirmed, 0 excluded

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

FDA 510(k) clearances by year

21984

11986

11987

51989

11990

51991

11993

42005

12006

42007

32008

12011

22013

12016

22018

22023

22024

12025

FDA listed device types

showing 8 of 40

Antistreptolysin - Titer/Streptolysin O Reagent 1Epstein-Barr Virus, Other 1Factor Xiii A, S, Antigen, Antiserum, Control 1Alpha-1-Acid-Glycoprotein, Antigen, Antiserum, Control 1Test, Antigen, Nuclear, Epstein-Barr Virus 1Controls For Blood-Gases, (Assayed And Unassayed) 1Radioimmunoassay, Dehydroepiandrosterone (Free And Sulfate) 1Enzyme Controls (Assayed And Unassayed) 1

Registration details (sample)

Market	Identifier	Name	Class / date
US	K243575	ARCHITECT HSV-2 IgG, ARCHITECT HSV-2 IgG Calibrator, ARCHITECT HSV-2 IgG Controls	2025-02-12
US	K233606	ADVIA Centaur EBV-VCA IgM	2024-08-07
US	K233605	ADVIA Centaur EBV-EBNA IgG	2024-08-07
BR	80003610521	Família HemosIL FDP	Class II
BR	80003610568	Família HemosIL HIT-Ab	Class II
BR	80003610598	HemosIL AcuStar Von Willebrand Factor Collagen Binding Activity	Class II
CA	68525	QUANTIA GENTAMICIN	Class II
CA	67573	BIOELISA HSV-1 IGG	Class II
CA	69219	BIOELISA RUBELLA IGG	Class II