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R.H. ELECTRONICS LTD.

Israel · Nof Hagalil Northern

✓ Record-verifiedregistrations found in 3 markets

This company has registrations in United States, Canada, South Korea — 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

15listed device types

Class I 3Class II 7Class III 5

plus 18 registration records and 10 510(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

1active device licences

Class II 1

2 including historic records

TWTaiwanTFDA

pendingnot queried

SGSingaporeHSA SMDR

pendingnot queried

KRSouth KoreaMFDS GMP

5GMP quality-system certificates

Import 5

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 States18 registration records, 10 510(k), 0 PMA, 383 excluded

Brazil0 confirmed, 48 excluded

Saudi Arabia0 confirmed, 19 excluded

Canada1 confirmed, 38 excluded

Manufacturer names merged into this page: A.L. ELECTRONICS LTD. · R.H. ELECTRONICS LTD. · D&D ELECTRONICS CO., LTD. · G&J ELECTRONICS INC.

Same-named companies — This database also contains companies with near-identical names: A.L. ELECTRONICS LTD., C.F. Electronics, Inc., D&D ELECTRONICS CO., LTD., G & J Electronics, Inc.. Company name alone cannot separate their registrations, so the figures below may include either.

FDA 510(k) clearances by year

11984

21989 · K892675

11992 · K921395

31993 · K926161

11996 · K955659

21999 · K991288

FDA listed device types

showing 8 of 15

Mr-Guided Focused Ultrasound System 1Electrical Tumor Treatment Fields 1Stimulator, Low Electric Field, Tumor Treatment 1Low Electric Field Generator For Pancreatic Cancer Treatment 1Electrical Tumor Treatment Fields For Non-Small Cell Lung Cancer 1Powered Light Based Non-Laser Surgical Instrument With Thermal Effect 1Over-The-Counter Radiofrequency Coagulation Device For Wrinkle Reduction 1Stimulator, Muscle, Powered, For Muscle Conditioning 1

Registration details (sample)

Market	Identifier	Name	Class / date
US	K991288	DISTENDER SERIES II BAROSTAT	1999-06-08
US	K973844	GASTRIC AND RECTAL CATHETERS	1999-06-04
US	K955659	DRUGBOX	1996-05-14
CA	76068	DISTENDER SERIES II BAROSTAT SYSTEM	Class II

R.H. ELECTRONICS LTD.

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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