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ONE LAMBDA, INC.

USA · West Hills

✓ 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

8listed device types

Class I 6Class II 1Class III 0unclassified 1

plus 65 registration records and 0 510(k)

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

6registered devices

Class I 6

18 including historic records

SASaudi ArabiaSFDA

0registered imported devices

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

CACanadaMDALL

2active device licences

Class III 2

19 including historic records

TWTaiwanTFDA

47valid device licences

Class I 5Class II 42

SGSingaporeHSA SMDR

17device registrations

CLASS C 17

KRSouth KoreaMFDS GMP

1GMP quality-system certificates

IVD import 1

AUAustraliaTGA ARTG

12active ARTG entries

IVD Class 2 1IVD Class 3 11

HKHong KongMDACS

6valid listings

IVD C 6

ILIsraelAMAR

9registrations

RURussiaRoszdravnadzor

2active registrations

Class 2b 2

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 States65 registration records, 0 510(k), 0 PMA, 3 excluded

Brazil6 confirmed, 0 excluded

Canada2 confirmed, 0 excluded

Manufacturer names merged into this page: ONE LAMBDA, INC. · ONE LAMBDA, INC · ONE LAMBDA INC

FDA listed device types

Test, Qualitative, For Hla, Non-Diagnostic 1Test, Leukocyte Typing 1Apparatus, Electrophoresis, For Clinical Use 1Station, Pipetting And Diluting, For Clinical Use 1Lymphocyte Separation Medium 1Automated Pipetting, Diluting And Specimen Processing Workstations For Flow Cytometric Analysis 1Stains, Hematology 1Human Leukocyte Antigen (Hla) Typing Companion Diagnostic Test 1

Registration details (sample)

Market	Identifier	Name	Class / date
BR	80298490108	FluoroQuench AO/EB	Class I
BR	80298490143	ESTREPTAVIDINA CONJUGADA COM FICOERITRINA LIOFILIZADA	Class I
BR	80298490140	TYPESTREAM VISUAL SOFTWARE DE ANÁLISE NGS	Class I
CA	62363	SSP UNITRAY	Class III
CA	69734	LABTYPE VISUAL SOFTWARE	Class III

ONE LAMBDA, INC.

Registrations by market

How these numbers were verified

Company information

FDA listed device types

Registration details (sample)

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