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UNOMEDICAL A/S

Denmark · Lejre

✓ Record-verifiedregistrations found in 9 markets

This company has registrations in United States, Brazil, Canada, Taiwan, South Korea, Australia, Hong Kong, Israel, Russia — 9 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

3listed device types

Class I 0Class II 3Class III 0

plus 15 registration records and 13 510(k)

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

8registered devices

Class II 8

9 including historic records

SASaudi ArabiaSFDA

0registered imported devices

low-risk imported devices only; a 2023 snapshot, not updated since

CACanadaMDALL

2active device licences

Class II 2

17 including historic records

TWTaiwanTFDA

1valid device licences

Class II 1

SGSingaporeHSA SMDR

pendingnot queried

KRSouth KoreaMFDS GMP

1GMP quality-system certificates

Import 1

AUAustraliaTGA ARTG

6active ARTG entries

IIb 6

HKHong KongMDACS

1valid listings

Class III 1

ILIsraelAMAR

15registrations

RURussiaRoszdravnadzor

3active registrations

Class 2a 1Class 2b 2

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 States15 registration records, 13 510(k), 0 PMA, 5 excluded

Brazil8 confirmed, 0 excluded

Canada2 confirmed, 2 excluded

Manufacturer names merged into this page: UNOMEDICAL A/S

FDA 510(k) clearances by year

12003

22004

12005

12006

12007

12012

12013

12016

12017

12018

12019

12021

FDA listed device types

Introducer, Syringe Needle 1Set, Administration, Intravascular 1Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days 1

Registration details (sample)

Market	Identifier	Name	Class / date
US	K210544	Medtronic Extended infusion set	2021-07-16
US	K192647	neria guard Infusion Set	2019-12-13
US	K173879	MiniMed Mio Advance infusion set	2018-03-05
BR	80523029042	Neria Guard Dispositivo para Infusão Subcutânea	Class II
BR	10349009017	Conjunto de Infusão MiniMed Sure-T	Class II
BR	81414021668	Accu-Chek TenderLink	Class II
CA	650	DRAIN BAG	Class II
CA	5424	CLINIPUR	Class II

UNOMEDICAL A/S

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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