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MARPAC, INC.

USA · Albuquerque

✓ Record-verifiedregistrations found in 4 markets

This company has registrations in United States, Saudi Arabia, Australia, Israel — 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

5listed device types

Class I 5Class II 0Class III 0

plus 5 registration records and 3 510(k)

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

0registered devices

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

SASaudi ArabiaSFDA

3registered imported devices

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

CACanadaMDALL

0active device licences

TWTaiwanTFDA

0valid device licences

SGSingaporeHSA SMDR

pendingnot queried

KRSouth KoreaMFDS GMP

pendingnot queried

AUAustraliaTGA ARTG

1active ARTG entries

Class I 1

HKHong KongMDACS

pendingnot queried

ILIsraelAMAR

1registrations

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 States5 registration records, 3 510(k), 0 PMA

Saudi Arabia3 confirmed, 0 excluded

Manufacturer names merged into this page: MARPAC, INC. · Marpac, Inc.

Registration details (sample)

Market	Identifier	Name	Class / date
US	K041485	MARPAC MESSENGER MODEL #501	2004-08-02
US	K940567	MODEL#1550 MARSONA(R) TINNITUS MASKER	1994-07-06
US	K802234	BEDSIDE TINNITUS MASKER #1500	1980-10-10
SA	ME0000007067SFDAA00001	Marpac ET Adhesive Tape Cloth Latex Free	—
SA	ME0000007067SFDAA00002	Marpac Adjustable Skin friendly ET tube Holder	—

MARPAC, 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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