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Iskra Medical d.o.o.

Slovenia · Ljubljana · www.iskramedical.eu

✓ Record-verifiedregistrations found in 6 marketsEU SRN SI-MF-000006345

This company has registrations in European Union, United States, United Kingdom, Brazil, Singapore, Australia — 6 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

31UDI-DI device records

Class IIa 31

USUnited StatesFDA openFDA

2listed device types

Class I 1Class II 1Class III 0

plus 2 registration records and 1 510(k)

UKUnited KingdomMHRA PARD

2registered device records

Class IIa 1Class IIb 1

BRBrazilANVISA

1registered devices

Class II 1

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

2device registrations

CLASS B 2

KRSouth KoreaMFDS GMP

pendingnot queried

AUAustraliaTGA ARTG

2active ARTG entries

IIa 2

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 Union31 raw hits, 0 excluded, 31 confirmed

United States2 registration records, 1 510(k), 0 PMA, 2 excluded

United Kingdom2 confirmed, 0 excluded

Brazil1 confirmed, 0 excluded

Manufacturer names merged into this page: ISKRA MEDICAL D O O · ISKRA MEDICAL D.O.O

Regulatory identity

EU manufacturer SRN: SI-MF-000006345
UK responsible person: Beautyform Medical Ltd

Registration details (sample)

Market	Identifier	Name	Class / date
EU	03830066952206	FMS Precision	Class IIa
EU	03830066952190	TESLA Face	Class IIa
EU	03830066952183	FMS Stym II	Class IIa
EU	03830066952176	FMS Care II	Class IIa
UK	58762	FMS Former	Class IIa
UK	11248	Sonic Shaper	Class IIb
US	K083590	ISKRA MEDICAL GREEN IRF PRESTIGE	2009-04-17
BR	81504799233	Estimulação Magnética Funcional	Class II

Iskra Medical d.o.o.

Registrations by market

How these numbers were verified

Regulatory identity

Company information

FDA 510(k) clearances by year

FDA listed device types

Registration details (sample)

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