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Sebia, Inc.

France · Evry Cedex

✓ Record-verifiedregistrations found in 9 markets

This company has registrations in United States, Brazil, Canada, Taiwan, Singapore, South Korea, Australia, Hong Kong, Israel — 9 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

28listed device types

Class I 9Class II 19Class III 0

plus 45 registration records and 34 510(k)

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

32registered devices

Class I 2Class II 30

40 including historic records

SASaudi ArabiaSFDA

0registered imported devices

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

CACanadaMDALL

17active device licences

Class II 17

35 including historic records

TWTaiwanTFDA

45valid device licences

Class I 19Class II 26

SGSingaporeHSA SMDR

24device registrations

CLASS B 22CLASS C 2

KRSouth KoreaMFDS GMP

1GMP quality-system certificates

IVD import 1

AUAustraliaTGA ARTG

7active ARTG entries

IVD Class 1 3IVD Class 2 4

HKHong KongMDACS

11valid listings

IVD B 9IVD C 2

ILIsraelAMAR

6registrations

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 States45 registration records, 34 510(k), 0 PMA

Brazil32 confirmed, 3 excluded

Canada17 confirmed, 0 excluded

Manufacturer names merged into this page: SEBIA

FDA 510(k) clearances by year

12002

12004

12005

12006

22007

12008

32009

22010

12011

32012

12013

12014

12015

12016

22017

32018

22019

12021

12022

22024

FDA listed device types

showing 8 of 28

Calibrator, Primary 1System, Analysis, Electrophoretic Hemoglobin 1Electrophoretic, Lactate Dehydrogenase Isoenzymes 1Control, Hemoglobin, Abnormal 1Assay, Fetal Hemoglobin 1Abnormal Hemoglobin Quantitation 1Nitrophenylphosphate, Alkaline Phosphatase Or Isoenzymes 1Assay, Glycosylated Hemoglobin 1

Registration details (sample)

Market	Identifier	Name	Class / date
US	K232027	CAPI 3 NEONAT Hb, CAPILLARYS 3 DBS Instrument	2024-04-04
US	K231601	FLC Kappa, FLC Lambda,FLC Control Level 1, FLC Control Level 2	2024-02-23
US	K210623	FLC Kappa, FLC Lambda, FLC Control Level 1, FLC Control Level 2	2022-11-18
BR	80416660087	CAPILLARYS 3 DBS	Class II
BR	80416660017	CAPILLARYS HEMOGLOBIN(E)	Class II
BR	80416660018	CAPILLARYS PROTEIN(E) 6	Class II
CA	3713	HYDRAGEL ISO-PAL	Class II
CA	4092	HYDRAGEL PROTEINURIA	Class II
CA	4867	HYDRAGEL LPE	Class II

Sebia, Inc.

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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