IUL SA

Spain · Barcelona · www.iul-instruments.com

✓ Record-verifiedregistrations found in 3 markets

This company has registrations in United States, United Kingdom, Taiwan — 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

0UDI-DI device records

USUnited StatesFDA openFDA

2listed device types

Class I 2Class II 0Class III 0

plus 2 registration records and 0 510(k)

UKUnited KingdomMHRA PARD

5registered device records

IVD A 2IVD general 3

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

1valid device licences

Class I 1

SGSingaporeHSA SMDR

pendingnot queried

KRSouth KoreaMFDS GMP

pendingnot queried

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.

European Union155 raw hits, 155 excluded, 0 confirmed

United States2 registration records, 0 510(k), 0 PMA

United Kingdom5 confirmed, 0 excluded

Manufacturer names merged into this page: IUL SA

Regulatory identity

UK responsible person: CMC Medical Devices LTD

Market	Identifier	Name	Class / date
UK	47057	iPeak® Europium	IVD A
UK	47057	iPeak® Europium	IVD general
UK	47057	iPeak® Europium	IVD general

IUL SA

Registrations by market

How these numbers were verified

Regulatory identity

Company information

FDA listed device types

Registration details (sample)

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