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ANSH LABS, LLC

USA · Webster

✓ Record-verifiedregistrations found in 5 markets

This company has registrations in United States, Brazil, Canada, Taiwan, Israel — 5 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

11listed device types

Class I 9Class II 2Class III 0

plus 12 registration records and 1 510(k)

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

5registered devices

Class II 5

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

4 including historic records

TWTaiwanTFDA

1valid device licences

Class II 1

SGSingaporeHSA SMDR

pendingnot queried

KRSouth KoreaMFDS GMP

pendingnot queried

AUAustraliaTGA ARTG

pendingnot queried

HKHong KongMDACS

pendingnot queried

ILIsraelAMAR

3registrations

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 States12 registration records, 1 510(k), 0 PMA

Brazil5 confirmed, 0 excluded

Manufacturer names merged into this page: ANSH LABS, LLC · ANSH LABS · ANSH LABS LLC

FDA 510(k) clearances by year

12018 · DEN180004

FDA listed device types

showing 8 of 11

Radioimmunoassay, Estriol 1Radioimmunoassay, Follicle-Stimulating Hormone 1Radioimmunoassay, Glucagon 1Multi-Analyte Controls, All Kinds (Assayed) 1Radioimmunoassay, Human Growth Hormone 1Radioimmunoassay, C-Peptides Of Proinsulin 1Radioimmunoassay, Luteinizing Hormone 1Radioimmunoassay, Prolactin (Lactogen) 1

Registration details (sample)

Market	Identifier	Name	Class / date
US	DEN180004	picoAMH ELISA	2018-10-24
BR	80464810812	Dried Blood Spot (DBS) AMH ELISA	Class II
BR	80464810820	Glucagon ELISA	Class II
BR	80464810836	DBS Follicle-Stimulating Hormone ELISA	Class II

ANSH LABS, LLC

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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