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MARINA MEDICAL INSTRUMENTS, INC.

USA · Davie

✓ Record-verifiedregistrations found in 5 markets

This company has registrations in United States, Brazil, Taiwan, Australia, Israel — 5 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

96listed device types

Class I 89Class II 7Class III 0

plus 99 registration records and 5 510(k)

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

18registered devices

Class I 17Class 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

0active device licences

TWTaiwanTFDA

1valid device licences

Class I 1

SGSingaporeHSA SMDR

pendingnot queried

KRSouth KoreaMFDS GMP

pendingnot queried

AUAustraliaTGA ARTG

6active ARTG entries

Class I 6

HKHong KongMDACS

pendingnot queried

ILIsraelAMAR

5registrations

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 States99 registration records, 5 510(k), 0 PMA, 1 excluded

Brazil18 confirmed, 0 excluded

Manufacturer names merged into this page: MARINA MEDICAL INSTRUMENTS, INC. · Marina Medical Instruments, Inc. · MARINA MEDICAL INSTRUMENTS INC.

FDA 510(k) clearances by year

12001 · K010296

32003 · K031463

12005 · K042534

FDA listed device types

showing 8 of 96

Camera, Still, Endoscopic 1Needle, Aspiration And Injection, Disposable 1Binder, Medical, Therapeutic 1Camera, Television, Microsurgical, Without Audio 1Accessories, Catheter 1Sound, Uterine 1Syringe, Irrigating (Non Dental) 1Retractor, Ent 1

Registration details (sample)

Market	Identifier	Name	Class / date
US	K042534	MARINA MEDICAL FINGER PROTECTORS	2005-05-10
US	K031463	MARINA MEDICAL SILICONE PESSARY	2003-11-18
US	K021876	MAS WITH OR WITHOUT SYRINGE	2003-04-08
BR	80646960003	MANIPULADOR UTERINO DESCARTÁVEL	Class II
BR	80646960010	AFASTADOR CIRÚRGICO	Class I
BR	80646960004	RASPADORES CIRÚRGICOS	Class I

MARINA MEDICAL INSTRUMENTS, 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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