HomeIsraelBioxtreme Ltd.

Bioxtreme Ltd.

Israel · Petach Tikva · www.bioxtremerobotics.com
✓ Record-verifiedregistrations found in 3 marketsEU SRN IL-MF-000047500

This company has registrations in European Union, United States, Israel — 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
2UDI-DI device records
Class I 2
USUnited StatesFDA openFDA
2listed device types
Class I 1Class II 1Class III 0
plus 2 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
3registrations
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 Union2 raw hits, 0 excluded, 2 confirmed
United States2 registration records, 0 510(k), 0 PMA
Manufacturer names merged into this page: BIOXTREME

Regulatory identity

EU manufacturer SRN
IL-MF-000047500
EU authorised representative
G&D&Y

Company information

Country
Israel
City
Petach Tikva
Website
www.bioxtremerobotics.com
Product categories
Clinical Diagnostics & Therapeutic TechnologiesOrthopaedics, Trauma & RehabilitationPhysiotherapy equipment

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.

FDA listed device types

Exerciser, Non-Measuring For Stroke Rehabilitation 1System, Isokinetic Testing And Evaluation 1

Registration details (sample)

MarketIdentifierNameClass / date
EU07290019197034PlaXtremeClass I
EU07290019197003DeXtremeClass I

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