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Advance Medical Designs, Inc.

USA · Marietta GA · advancemedicaldesigns.com

✓ Record-verifiedregistrations found in 7 markets

This company has registrations in United States, United Kingdom, Saudi Arabia, Canada, Taiwan, Australia, Israel — 7 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

0UDI-DI device records

USUnited StatesFDA openFDA

25listed device types

Class I 11Class II 14Class III 0

plus 36 registration records and 32 510(k)

UKUnited KingdomMHRA PARD

5registered device records

Class I 5

BRBrazilANVISA

0registered devices

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

SASaudi ArabiaSFDA

7registered imported devices

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

CACanadaMDALL

1active device licences

Class II 1

TWTaiwanTFDA

2valid device licences

Class I 2

SGSingaporeHSA SMDR

pendingnot queried

KRSouth KoreaMFDS GMP

pendingnot queried

AUAustraliaTGA ARTG

12active ARTG entries

Class I 3Class Is (sterile) 9

HKHong KongMDACS

pendingnot queried

ILIsraelAMAR

10registrations

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.

European Union2,275 raw hits, 300 excluded, 0 confirmed. Large result set — only the first 300 verified

United States36 registration records, 32 510(k), 0 PMA, 16 excluded

United Kingdom5 confirmed, 49 excluded

Brazil0 confirmed, 2 excluded

Saudi Arabia7 confirmed, 4 excluded

Canada1 confirmed, 1 excluded

Manufacturer names merged into this page: ADVANCE MEDICAL DESIGNS, INC. · Advance Medical Designs Inc · Advance Medical Designs,Inc · Advance Medical Designs, Inc.

Regulatory identity

UK responsible person: MDSS-UK RP LIMITED

FDA 510(k) clearances by year

51985

71989

91990

11991

11992

21994

42001

12006

12017

12023

FDA listed device types

showing 8 of 25

Cover, Limb 1Protector, Skin Pressure 1Container, Specimen, Non-Sterile 1Head Halter, Traction 1Microscope, Operating & Accessories, Ac-Powered, Ophthalmic 1Stretcher, Patient Restraint 1Guide, Needle, Surgical 1Bedding, Disposable, Medical 1

Registration details (sample)

Market	Identifier	Name	Class / date
UK	58848	Urological Drain Bag	Class I
UK	12535	Equipment Cover	Class I
UK	45018	Advance Medical Designs Needle Guides and Grids	Class I
US	K223689	Disposable Needle Guides and Grids	2023-08-02
US	K163050	Advance Medical Designs, Inc. Sterile Ultrasound Gel	2017-10-25
US	K053495	EQUIPMENT SLUSH DRAPE	2006-03-16
SA	ME0000013174SFDAA00001	Infection Control System	—
SA	ME0000012832SFDAA00003	Patient Positioning Belt	—
CA	62985	PRESSURE MONITORING LINE	Class II

Advance Medical Designs, Inc.

Registrations by market

How these numbers were verified

Regulatory identity

Company information

FDA 510(k) clearances by year

FDA listed device types

Registration details (sample)

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