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KOVAL d.o.o.

Slovenia · Loka Pri Žusmu · www.koval.si

✓ Record-verifiedregistrations found in 2 markets

This company has registrations in United Kingdom, Australia — 2 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

0listed device types

Class I 0Class II 0Class III 0

plus 0 registration records and 0 510(k)

UKUnited KingdomMHRA PARD

9registered device records

Class I 9

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

pendingnot queried

SGSingaporeHSA SMDR

pendingnot queried

KRSouth KoreaMFDS GMP

pendingnot queried

AUAustraliaTGA ARTG

4active ARTG entries

Class I 4

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 Union139 raw hits, 139 excluded, 0 confirmed

United Kingdom9 confirmed, 0 excluded

Regulatory identity

UK responsible person: Wealden Rehab Ltd

Market	Identifier	Name	Class / date
UK	43494	Shower Trolley L1-EL	Class I
UK	42486	EXAMINATION – TREATMENT TABLE SPECIAL L1-HYD-KC-HELIO1	Class I
UK	31362	Helio 1 - Bariatric	Class I

KOVAL d.o.o.

Registrations by market

How these numbers were verified

Regulatory identity

Company information

Registration details (sample)

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