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Ohio Medical Instrument Co., Inc.

USA · Wrentham

✓ Record-verifiedregistrations found in 2 markets

This company has registrations in United States, Canada — 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

9listed device types

Class I 5Class II 4Class III 0

plus 13 registration records and 21 510(k)

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

0registered devices

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

4active device licences

Class II 4

12 including historic records

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, 21 510(k), 0 PMA, 13 excluded

Brazil0 confirmed, 1 excluded

Canada4 confirmed, 1 excluded

Manufacturer names merged into this page: Ohio Medical LLC · OHIO MEDICAL LLC

Same-named companies — This database also contains companies with near-identical names: Ohio Medical Products, Ohio Medical Research, Inc.. Company name alone cannot separate their registrations, so the figures below may include either.

FDA 510(k) clearances by year

21983

21985

11989

11990

31993

11994

11995

21996

21998

21999

22002

12006

12008

FDA listed device types

showing 8 of 9

Flowmeter, Tube, Thorpe, Back-Pressure Compensated 1Regulator, Pressure, Gas Cylinder 1Tubing, Pressure And Accessories 1Flowmeter, Nonback-Pressure Compensated, Bourdon Gauge 1Humidifier, Non-Direct Patient Interface (Home-Use) 1Generator, Oxygen, Portable 1Regulator, Vacuum 1Pump, Portable, Aspiration (Manual Or Powered) 1

Registration details (sample)

Market	Identifier	Name	Class / date
US	K081185	MOBLVAC W.C.	2008-05-02
US	K062610	CARE-E-VAC 3	2006-09-28
US	K021604	MAYFIELD RADIOLUCENT SKULL PINS, MODEL 4-0-A-2020	2002-07-29
CA	65307	VENTURI/EJECTOR SUCTION MODULE	Class II
CA	76706	AIR-OXYGEN BLENDER	Class II
CA	88221	REUSABLE HUMIDIFIER BOTTLE	Class II

Ohio Medical Instrument Co., 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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