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Mercury Medical, Inc.

USA · Clearwater

✓ Record-verifiedregistrations found in 9 markets

This company has registrations in United States, Brazil, Saudi Arabia, Canada, Taiwan, Singapore, Australia, Israel, Russia — 9 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

21listed device types

Class I 9Class II 12Class III 0

plus 31 registration records and 18 510(k)

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

3registered devices

Class II 3

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

SASaudi ArabiaSFDA

2registered imported devices

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

CACanadaMDALL

1active device licences

Class II 1

21 including historic records

TWTaiwanTFDA

1valid device licences

Class I 1

SGSingaporeHSA SMDR

1device registrations

CLASS C 1

KRSouth KoreaMFDS GMP

pendingnot queried

AUAustraliaTGA ARTG

9active ARTG entries

Class I 4IIa 4Class Im (measuring) 1

HKHong KongMDACS

pendingnot queried

ILIsraelAMAR

1registrations

RURussiaRoszdravnadzor

6active registrations

Class 2a 5Class 2b 1

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 States31 registration records, 18 510(k), 0 PMA, 5 excluded

Brazil3 confirmed, 0 excluded

Saudi Arabia2 confirmed, 0 excluded

Canada1 confirmed, 0 excluded

Manufacturer names merged into this page: MERCURY MEDICAL · Mercury Medical

FDA 510(k) clearances by year

21994

41996

11997

22000

12002

22003

12004

32009

12010

12014

FDA listed device types

showing 8 of 21

Spirometer, Therapeutic (Incentive) 1Filter, Bacterial, Breathing-Circuit 1Monitor, Airway Pressure (Includes Gauge And/Or Alarm) 1Nebulizer (Direct Patient Interface) 1Attachment, Breathing, Positive End Expiratory Pressure 1Tubes, Gastrointestinal (And Accessories) 1Resuscitator, Manual, Non Self-Inflating 1Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase 1

Registration details (sample)

Market	Identifier	Name	Class / date
US	K142096	T-PIECE RESUSCITATOR	2014-10-17
US	K093913	MERCURY MEDICAL T-PIECE RESUSCITATOR	2010-04-06
US	K090710	MERCURY CPAP	2009-08-20
BR	10234400113	RESSUSCITADOR CARDIOPULMONAR (CPR) MERCURY MEDICAL	Class II
BR	10234409007	RESSUSCITADOR INFANTIL COM CONECTOR T NEO-TEE	Class II
BR	10234400116	CPAP DESCARTÁVEL FLOW-SAFE	Class II
SA	ME0000000494SFDAA00005	SILICONE FACE MASK	—
SA	ME0000000494SFDAA00004	Face-Cradle	—
CA	18603	LARYNGOSCOPES/BLADES	Class II

Mercury Medical, 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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