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HARMAC MEDICAL PRODUCTS, INC.

Ireland · Castlerea Roscommon

✓ Record-verifiedregistrations found in 3 markets

This company has registrations in United States, Taiwan, 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

35listed device types

Class I 7Class II 23Class III 3unclassified 2

plus 63 registration records and 8 510(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

0active device licences

TWTaiwanTFDA

2valid device licences

Class II 2

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 States63 registration records, 8 510(k), 0 PMA, 1 excluded

Manufacturer names merged into this page: HARMAC MEDICAL PRODUCTS, INC./H3 de Tijuana, S. de RL de C.V. · HARMAC MEDICAL PRODUCTS, INC./H3 de Tijuana, S. de RL de CV · HARMAC MEDICAL PRODUCTS · HARMAC MEDICAL PRODUCTS, INC.

FDA 510(k) clearances by year

11995 · K950895

61997 · K962829

12002 · K021916

FDA listed device types

showing 8 of 35

Electrosurgical, Cutting & Coagulation & Accessories 1Apparatus, Cautery, Radiofrequency, Ac-Powered 1System, Suction, Lipoplasty For Removal 1Photocoagulator And Accessories 1Catheter, Intravascular, Diagnostic 1Unit, Phacofragmentation 1Lipoaspirate Washing System For Aesthetic Body Contouring 1Laparoscope, General & Plastic Surgery 1

Registration details (sample)

Market	Identifier	Name	Class / date
US	K021916	HARMAC HUBER NEEDLE SAFETY DEVICE, H2984001	2002-08-29
US	K962829	HARMAC BALLOON ANGIOGRAPHIC CATHETER	1997-10-16
US	K963335	HARMAC BALLOON WEDGE PRESSURE CATHETER	1997-10-16

HARMAC MEDICAL PRODUCTS, 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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