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WR MEDICAL ELECTRONICS CO.

USA · Maplewood

✓ Record-verifiedregistrations found in 7 markets

This company has registrations in United States, Canada, Taiwan, Singapore, South Korea, Australia, Israel — 7 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 1Class II 4Class III 0

plus 7 registration records and 6 510(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

2active device licences

Class II 2

9 including historic records

TWTaiwanTFDA

3valid device licences

Class II 3

SGSingaporeHSA SMDR

4device registrations

CLASS B 4

KRSouth KoreaMFDS GMP

2GMP quality-system certificates

Import 2

AUAustraliaTGA ARTG

10active ARTG entries

Class I 3IIa 6Class Im (measuring) 1

HKHong KongMDACS

pendingnot queried

ILIsraelAMAR

4registrations

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 States7 registration records, 6 510(k), 0 PMA

Canada2 confirmed, 0 excluded

Manufacturer names merged into this page: WR MEDICAL ELECTRONICS CO. · WR MEDICAL ELECTRONICS CO

FDA 510(k) clearances by year

11990 · K895838

11992 · K910624

11999 · K992874

12000 · K000574

12007 · K063560

12010 · K092809

FDA listed device types

Device, Vibration Threshold Measurement 1Device, Iontophoresis, Other Uses 1Device, Iontophoresis, Specific Uses 1Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm) 1Bath, Paraffin 1

Registration details (sample)

Market	Identifier	Name	Class / date
US	K092809	HRV ACQUIRE	2010-10-19
US	K063560	HILGER DUAL-STIM NERVE STIMULATOR	2007-01-05
US	K000574	IONTOPHORETIC DRUG DELIVERY ELECTRODE, IONTOPHORETIC ELECTRODE (ACTIVE)	2000-08-09
CA	9617	BRACKMAN II	Class II
CA	70784	SPA PETITE BY THERABATH	Class II

WR MEDICAL ELECTRONICS CO.

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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