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DPE Medical Ltd.

✓ Record-verifiedregistrations found in 6 marketsEU SRN IL-MF-000042640

This company has registrations in European Union, United States, Taiwan, Australia, Israel, Russia — 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

8UDI-DI device records

Class I 8

USUnited StatesFDA openFDA

1listed device types

Class I 1Class II 0Class III 0

plus 1 registration records and 0 510(k)

UKUnited KingdomMHRA PARD

0registered device records

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

2active ARTG entries

Class I 2

HKHong KongMDACS

pendingnot queried

ILIsraelAMAR

1registrations

RURussiaRoszdravnadzor

1active registrations

Class 2a 1

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 Union96 raw hits, 88 excluded, 8 confirmed

United States1 registration records, 0 510(k), 0 PMA

United Kingdom0 confirmed, 2 excluded

Manufacturer names merged into this page: DPE MEDICAL LTD.

Regulatory identity

EU manufacturer SRN: IL-MF-000042640
EU authorised representative: Obelis s.a.

Market	Identifier	Name	Class / date
EU	G535DSTSoB0	Sense of Balance	Class I
EU	G535DSTTS0	DST Triple Sense	Class I
EU	G535DSTTPX0	DST8000 Triple Pro XL	Class I
EU	G535DSTTP0	DST8000 Triple Pro	Class I

DPE Medical Ltd.

Registrations by market

How these numbers were verified

Regulatory identity

Company information

FDA listed device types

Registration details (sample)

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