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MEDI USA, LP

USA · Whitsett

✓ Record-verifiedregistrations found in 2 markets

This company has registrations in United States, Brazil — 2 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

7listed device types

Class I 5Class II 2Class III 0

plus 8 registration records and 6 510(k)

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

4registered devices

Class I 4

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

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 States8 registration records, 6 510(k), 0 PMA, 87 excluded

Brazil4 confirmed, 20 excluded

Saudi Arabia0 confirmed, 11 excluded

Canada0 confirmed, 14 excluded

Manufacturer names merged into this page: MEDI USA, LP · Medi USA L.P.

FDA 510(k) clearances by year

11994 · K941926

12005 · K051324

12009 · K083455

12012 · K121703

12019 · K183631

12022 · K221654

FDA listed device types

Stocking, Medical Support (To Prevent Pooling Of Blood In Legs) 1Sleeve, Limb, Compressible 1Foot Wrap For Treating Restless Leg Syndrome Symptoms 1Binder, Medical, Therapeutic 1Binder, Elastic 1Stocking, Medical Support (For General Medical Purposes) 1Stocking, Elastic 1

Registration details (sample)

Market	Identifier	Name	Class / date
US	K221654	medi pneumatic compression system (pcs)-genius (Model 652)	2022-07-07
US	K183631	medi pneumatic compression system (pcs) brio (Model 651)	2019-01-25
US	K121703	LIPOKIT WITH DISPOSABLE 50CC AFT SYRINGE	2012-12-07
BR	81380060009	MEDIVEN ASSURE	Class I
BR	81380060010	MEDIVEN FOR MEN	Class I
BR	81380060011	MEDIVEN SHEER & SOFT	Class I

MEDI USA, LP

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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