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Prestige Ameritech , Ltd.

USA · North Richland Hills

✓ Record-verifiedregistrations found in 2 markets

This company has registrations in United States, Israel — 2 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

13listed device types

Class I 9Class II 4Class III 0

plus 25 registration records and 6 510(k)

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

0registered devices

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

TWTaiwanTFDA

pendingnot queried

SGSingaporeHSA SMDR

pendingnot queried

KRSouth KoreaMFDS GMP

pendingnot queried

AUAustraliaTGA ARTG

pendingnot queried

HKHong KongMDACS

pendingnot queried

ILIsraelAMAR

1registrations

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 States25 registration records, 6 510(k), 0 PMA

Canada0 confirmed, 1 excluded

Manufacturer names merged into this page: PRESTIGE AMERITECH

FDA 510(k) clearances by year

12006 · K061716

12010 · K102092

22016 · K160100

12017 · K171162

12024 · K231741

FDA listed device types

showing 8 of 13

Accessory, Surgical Apparel 1Gown, Examination 1Surgeon'S Gloves 1Holder, Ureteral Catheter 1Polymer Patient Examination Glove 1Medical Glove, Specialty 1Shield, Protective, Personnel 1Tape And Bandage, Adhesive 1

Registration details (sample)

Market	Identifier	Name	Class / date
US	K231741	ProGear® Surgical Mask with Oxafence®, Model AV82030	2024-09-05
US	K171162	Surgical Earloop Face Mask with Bottom Gap Shield and Surgical Tie-On Face Mask with Bottom Gap Shield	2017-08-15
US	K160100	Prestige Ameritech Pediatric/Childs Face mask	2016-10-07

Prestige Ameritech , Ltd.

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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