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Sigma Medical, Inc.

USA · Indianapolis

✓ Record-verifiedregistrations found in 3 markets

This company has registrations in United States, Saudi Arabia, Canada — 3 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

2listed device types

Class I 0Class II 2Class III 0

plus 3 registration records and 19 510(k)

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

0registered devices

this export covers Class I / II only (the cadastro route)

SASaudi ArabiaSFDA

4registered imported devices

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

CACanadaMDALL

1active device licences

Class III 1

TWTaiwanTFDA

pendingnot queried

SGSingaporeHSA SMDR

pendingnot queried

KRSouth KoreaMFDS GMP

pendingnot queried

AUAustraliaTGA ARTG

pendingnot queried

HKHong KongMDACS

pendingnot queried

ILIsraelAMAR

pendingnot queried

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 States3 registration records, 19 510(k), 0 PMA, 23 excluded

Brazil0 confirmed, 3 excluded

Saudi Arabia4 confirmed, 0 excluded

Canada1 confirmed, 4 excluded

Manufacturer names merged into this page: SIGMA MEDICAL SUPPLIES CORP. · FIRST MEDICAL, INC. (A SIGMA DIAGNOSTICS COMPANY) · SIGMA Medical Supplies Corp · Yalcin Okat Steri Sigma Medical

Registration details (sample)

Market	Identifier	Name	Class / date
US	K202462	SIGMA Sterilization Pouch and Roll	2021-04-23
US	K180672	Sterilization Pouch/Roll Made with Tyvek	2018-06-06
US	K180661	SIGMA Sterilization Pouch and Roll	2018-06-05
SA	ME0000007908SFDAA00002	Flat Sterilization Rolls	—
SA	ME0000000080SFDAA00001	Tyvek Sterilization Rolls	—
CA	31528	ALPHA DX POINT-OF-NEED SYSTEM	Class III

Sigma Medical, 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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