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Medical Design, LLC

USA · Brandon

✓ Record-verifiedregistrations found in 4 markets

This company has registrations in United States, Brazil, Canada, Australia — 4 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

18listed device types

Class I 14Class II 4Class III 0

plus 18 registration records and 31 510(k)

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

1registered devices

Class II 1

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

11active device licences

Class II 10Class III 1

13 including historic records

TWTaiwanTFDA

pendingnot queried

SGSingaporeHSA SMDR

pendingnot queried

KRSouth KoreaMFDS GMP

pendingnot queried

AUAustraliaTGA ARTG

12active ARTG entries

Class I 12

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 States18 registration records, 31 510(k), 0 PMA, 143 excluded

Brazil1 confirmed, 7 excluded

Saudi Arabia0 confirmed, 1 excluded

Canada11 confirmed, 9 excluded

Manufacturer names merged into this page: ADVANCED MEDICAL DESIGN CO., LTD. · LG MEDICAL DESIGN, LLC · NORTHEAST MEDICAL SYSTEMS AND DESIGN, LLC · BIRD LIFE DESIGN-BLD MEDICAL PRODUCTS · DRIVE MEDICAL DESIGN & MANUFACTURING · INRO MEDICAL DESIGN, INC.

FDA 510(k) clearances by year

21981

21982

11984

21986

11988

11989

11990

21991

21992

11994

11999

12002

22004

12010

42012

22013

12014

12016

22019

12021

FDA listed device types

showing 8 of 18

Tubing/Tubing With Filter, Insufflation, Laparoscopic 1Instrument, Ligature Passing And Knot Tying 1Accessories, Cleaning Brushes, For Endoscope 1Mouthpiece, Breathing 1Circuit, Breathing (W Connector, Adaptor, Y Piece) 1Stirrup, External Brace Component 1Mask, Oxygen 1Instrument, Manual, Surgical, General Use 1

Registration details (sample)

Market	Identifier	Name	Class / date
US	K210248	Lab Bag with Fabric Pouch	2021-07-30
US	K181887	AMD Anti-Fog Solution	2019-01-22
US	K182635	Signal Catheter	2019-01-10
BR	81528780006	Patch estéril para Leito Ungueal	Class II
CA	12809	ANAESTHESIA CIRCUIT BABYSET	Class II
CA	89978	FUTURE AIR TRUE LOW AIR LOSS MATTRESS SYSTEM	Class II
CA	85123	SELF ADHESIVE ELECTRODES	Class II

Medical Design, LLC

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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