HomeIsraelButterfly Medical Ltd.

Butterfly Medical Ltd.

Israel · Yokneam Illit · www.butterfly-medical.com
✓ Record-verifiedregistrations found in 2 marketsEU SRN IL-MF-000021414

This company has registrations in European Union, Israel — 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
6UDI-DI device records
Class IIb 6
USUnited StatesFDA openFDA
0listed device types
Class I 0Class II 0Class III 0
plus 0 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
pendingnot queried
SGSingaporeHSA SMDR
pendingnot queried
KRSouth KoreaMFDS GMP
pendingnot queried
AUAustraliaTGA ARTG
pendingnot queried
HKHong KongMDACS
pendingnot queried
ILIsraelAMAR
1registrations
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 Union13 raw hits, 7 excluded, 6 confirmed
United States0 registration records, 0 510(k), 0 PMA, 2 excluded
United Kingdom0 confirmed, 2 excluded
Brazil0 confirmed, 1 excluded
Canada0 confirmed, 1 excluded

Regulatory identity

EU manufacturer SRN
IL-MF-000021414
EU authorised representative
MedNet EC-REP IIb GmbH

Company information

Country
Israel
City
Yokneam Illit
Website
www.butterfly-medical.com
Product categories
Clinical Diagnostics & Therapeutic TechnologiesMedical Devices & Clinical EquipmentSurgical systems & instruments

Fields marked "pending" have not been obtained yet; that does not mean they do not exist. Risk records (litigation, penalties, operating anomalies) are kept internal and not published.

Registration details (sample)

MarketIdentifierNameClass / date
EU07290017685168Butterfly prostatic retraction device size XLClass IIb
EU07290017685120Butterfly prostatic retraction device size SClass IIb
EU07290017685410Measurement rod (size indicator)Class IIb
EU07290017685151Butterfly prostatic retraction device size LClass IIb

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