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IPAX, INC.

USA · Englewood

✓ 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

11listed device types

Class I 2Class II 6Class III 1unclassified 2

plus 13 registration records and 18 510(k)

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

2registered devices

Class II 2

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 States13 registration records, 18 510(k), 0 PMA

Brazil2 confirmed, 0 excluded

Manufacturer names merged into this page: IPAX, INC. · Ipax, Inc

FDA 510(k) clearances by year

21984

51986

31987

11988

31991

11992

21997

12021

FDA listed device types

showing 8 of 11

Filler, Bone Void, Calcium Compound 1System, Suction, Lipoplasty 1Set, I.V. Fluid Transfer 1Chamber, Oxygen, Topical, Extremity 1Set, Administration, Intravascular 1Continuous Measurement Thermometer 1Dressing, Wound, Drug 1Wound Dressing With Animal-Derived Material(S) 1

Registration details (sample)

Market	Identifier	Name	Class / date
US	K200893	ProntoPump Sterile Tube Set	2021-05-04
US	K971242	BLINK GOLD EVELID WEIGHT (BG 06 THRU BG 28)	1997-12-17
US	K971245	BLINK EXTERNAL EYELID WEIGHT	1997-06-20
BR	80894180001	RECIPIENTE DE TECIDOS GID SVF-1	Class II
BR	80894180002	RECIPIENTE DE TECIDOS GID 700	Class II

IPAX, 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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