Home›USA›Unomedical Sdn Bhd

Unomedical Sdn Bhd

USA · Mcallen

✓ Record-verifiedregistrations found in 4 markets

This company has registrations in United States, Canada, Israel, Russia — 4 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

9510(k) clearances

Class I 0Class II 0Class III 0

plus 0 registration records and 9 510(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

47active device licences

Class II 47

50 including historic records

TWTaiwanTFDA

0valid device licences

SGSingaporeHSA SMDR

pendingnot queried

KRSouth KoreaMFDS GMP

pendingnot queried

AUAustraliaTGA ARTG

pendingnot queried

HKHong KongMDACS

pendingnot queried

ILIsraelAMAR

3registrations

RURussiaRoszdravnadzor

5active registrations

Class 1 2Class 2a 3

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 States0 registration records, 9 510(k), 0 PMA, 6 excluded

Brazil0 confirmed, 1 excluded

Canada47 confirmed, 1 excluded

Manufacturer names merged into this page: UNOMEDICAL INC. · UNOMEDICAL SDN BHD

Registration details (sample)

Market	Identifier	Name	Class / date
US	K973076	EUROMEDICAL HAEMATURIA FOLEY CATHETER	1998-09-16
US	K962389	EUROMEDICAL REINFORCED ENDOTRACHEAL TUBE	1996-11-21
US	K954751	SILICONE ENDOTRACHEAL TUBE	1995-12-08
CA	4097	MEDICATION NEUBULIZER WITH PEDIATRIC AEROSOL MASK NAD 7FT TUBING	Class II
CA	4103	BUBBLE HUMIDIFIER	Class II
CA	4105	PEDIATRIC AND ADULT AEROSOL MASK (UNDER THE CHIN) ELONGATED	Class II

Unomedical Sdn Bhd

Registrations by market

How these numbers were verified

Company information

FDA 510(k) clearances by year

Registration details (sample)

Similar companies