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ATLAS MEDICAL

Jordan · Amman Al '??Imah

✓ Record-verifiedregistrations found in 5 markets

This company has registrations in United States, Brazil, Canada, Singapore, Australia — 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

76listed device types

Class I 52Class II 23Class III 0unclassified 1

plus 66 registration records and 3 510(k)

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

3registered devices

Class II 3

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

7active device licences

Class II 7

37 including historic records

TWTaiwanTFDA

0valid device licences

SGSingaporeHSA SMDR

5device registrations

CLASS B 5

KRSouth KoreaMFDS GMP

pendingnot queried

AUAustraliaTGA ARTG

3active ARTG entries

Class I 3

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 States66 registration records, 3 510(k), 0 PMA, 13 excluded

Brazil3 confirmed, 1 excluded

Canada7 confirmed, 1 excluded

Manufacturer names merged into this page: ATLAS MEDICAL PRODUCTS LLC · ATLAS MEDICAL · ATLAS MEDIC INC.

FDA 510(k) clearances by year

11991 · K914100

12011 · K102760

12019 · K191099

FDA listed device types

showing 8 of 76

Cap, Surgical 1Gauze / Sponge,Nonresorbable For External Use 1Container, Specimen, Sterile 1Azo-Dyes, Colorimetric, Bilirubin & Its Conjugates (Urinary, Non-Quant.) 1Test, Luteinizing Hormone (Lh), Over The Counter 1Circuit, Breathing (W Connector, Adaptor, Y Piece) 1Appliance, Colostomy, Disposable 1Solvent, Adhesive Tape 1

Registration details (sample)

Market	Identifier	Name	Class / date
US	K191099	Atlas Multi-Drugs Screening Test Cup, Atlas Multi-Drugs Screening Test Panel	2019-10-03
US	K102760	ATLAS HOME PREGNANCY TEST (MIDSTREAM FORMAT) MODEL 70172001	2011-08-03
US	K914100	STETHOSCOPE	1991-11-07
BR	80113770010	Família Maternitest	Class II
BR	80113770011	Família Strip Easy Test Alexdan	Class II
BR	80113770012	Família Easy Test Plus Alexdan	Class II
CA	89893	DIGITAL HAND DYNAMOMETER	Class II
CA	98005	DISPOSABLE ELECTRODES ECG	Class II
CA	98006	RESTING ECG SYSTEMS	Class II

ATLAS MEDICAL

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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