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American Eagle Instruments, Inc.

USA · Missoula

✓ Record-verifiedregistrations found in 8 markets

This company has registrations in United States, Brazil, Saudi Arabia, Canada, Taiwan, Australia, Israel, Russia — 8 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 27Class II 1Class III 0

plus 31 registration records and 2 510(k)

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

3registered devices

Class I 3

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

SASaudi ArabiaSFDA

1registered imported devices

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

CACanadaMDALL

0active device licences

1 including historic records

TWTaiwanTFDA

2valid device licences

Class I 2

SGSingaporeHSA SMDR

pendingnot queried

KRSouth KoreaMFDS GMP

pendingnot queried

AUAustraliaTGA ARTG

8active ARTG entries

Class I 8

HKHong KongMDACS

pendingnot queried

ILIsraelAMAR

1registrations

RURussiaRoszdravnadzor

2active registrations

Class 2a 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 States31 registration records, 2 510(k), 0 PMA, 24 excluded

Brazil3 confirmed, 3 excluded

Saudi Arabia1 confirmed, 2 excluded

Canada0 confirmed, 2 excluded

Manufacturer names merged into this page: AMERICAN EAGLE INSTRUMENTS · AMERICAN EAGLE INSTRUMENTS INC · AMERICAN EAGLE INSTRUMENTS INC. · American Eagle Instruments

FDA 510(k) clearances by year

12005 · K042972

12013 · K122501

FDA listed device types

showing 8 of 28

Curette, Periodontic 1Clamp 1Handle, Scalpel 1Elevator, Surgical, Dental 1Chisel, Osteotome, Surgical 1Instruments, Dental Hand 1Excavator, Dental, Operative 1Handle, Instrument, Dental 1

Registration details (sample)

Market	Identifier	Name	Class / date
US	K122501	AEI DR. TERAUCHI ULTRASONIC TIPS	2013-03-29
US	K042972	XP TECHNOLOGY ULTRASONIC SCALER	2005-03-18
BR	10347940154	IMPLANT INSTRUMENTS - American Eagle	Class I
BR	10347940155	INSTRUMENTOS NÃO ARTICULADOS CORTANTES - American Eagle	Class I
BR	10347940157	INSTRUMENTOS NÃO ARTICULADOS NÃO CORTANTES -American Eagle	Class I
SA	ME0000004819SFDAA00001	CARVER	—

American Eagle Instruments, 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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