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ROCHESTER MEDICAL CORPORATION

USA · Stewartville

✓ Record-verifiedregistrations found in 3 markets

This company has registrations in United States, Canada, Israel — 3 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

1listed device types

Class I 1Class II 0Class III 0

plus 1 registration records and 15 510(k), 3 PMA

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

9active device licences

Class II 9

TWTaiwanTFDA

0valid device licences

SGSingaporeHSA SMDR

pendingnot queried

KRSouth KoreaMFDS GMP

pendingnot queried

AUAustraliaTGA ARTG

pendingnot queried

HKHong KongMDACS

pendingnot queried

ILIsraelAMAR

3registrations

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 States1 registration records, 15 510(k), 3 PMA, 1 excluded

Brazil0 confirmed, 1 excluded

Canada9 confirmed, 1 excluded

Manufacturer names merged into this page: ROECHLING MEDICAL ROCHESTER L.P. · ROCHESTER ELECTRO-MEDICAL, INC. · ROCHESTER MEDICAL CORPORATION

Registration details (sample)

Market	Identifier	Name	Class / date
US	K142159	DISPOSABLE PRE-GELLED SURFACE ELECTRODE	2015-06-03
US	K122785	HYDROSIL; MAGIC; PERSONAL CATHETER	2013-05-14
US	K080914	ULTRASHARP CONCENTRIC NEEDLES	2008-07-15
CA	63693	RESPIRATION MONITORS	Class II
CA	63694	MOTION TRANSDUCER BUTTON	Class II
CA	63698	CARDIO-PNEUMOGRAPH RESPIRATION MONITOR	Class II

ROCHESTER MEDICAL CORPORATION

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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