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Eagle Medical, Inc.

USA · Trophy Club

✓ Record-verifiedregistrations found in 3 markets

This company has registrations in United States, Brazil, Saudi Arabia — 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

43listed device types

Class I 10Class II 32Class III 0unclassified 1

plus 71 registration records and 7 510(k)

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

3registered devices

Class I 3

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

SASaudi ArabiaSFDA

2registered 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

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 States71 registration records, 7 510(k), 0 PMA, 21 excluded

Brazil3 confirmed, 3 excluded

Saudi Arabia2 confirmed, 1 excluded

Canada0 confirmed, 3 excluded

Manufacturer names merged into this page: RISING EAGLE MEDICAL · EAGLE MEDICAL PACKAGING STERILIZATION, INC. · SHANDONG DOUBLE EAGLE MEDICAL DEVICES CO, LTD. · Shadong Double Eagle Medical Device Co., Ltd · Shandong Double Eagle Medical Device Co Ltd

FDA 510(k) clearances by year

11983 · K831819

11989 · K891795

21993 · K933661

11994 · K933618

11996 · K955129

12007 · K062724

FDA listed device types

showing 8 of 43

Posterior Cervical Screw System 1Rod, Fixation, Intramedullary And Accessories 1Thoracolumbosacral Pedicle Screw System 1Appliance, Fixation, Spinal Intervertebral Body 1Intervertebral Fusion Device With Bone Graft, Lumbar 1Cerclage, Fixation 1Screw, Fixation, Bone 1Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented 1

Registration details (sample)

Market	Identifier	Name	Class / date
US	K062724	ACCUPULSE PULSE OXIMETER	2007-05-11
US	K955129	OXYPULSE EOC I, EOC II & EOC R	1996-02-16
US	K933618	EAGLE MEDICAL ANTI-FOG KIT	1994-03-07
BR	82009150009	Vestimenta de Proteção Radiológica Shandong	Class I
BR	82009150010	Óculos de Proteção Radiológica Shandong	Class I
BR	82009150007	Luvas de Proteção Radiológica Shandong	Class I
SA	ME0000005593SFDAA00001	Layan ® Apron	—
SA	ME0000009106SFDAA00001	DOUBLE EAGLE	—

Eagle 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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