HomeIsraelInovytec Medical Solutions Ltd.

Inovytec Medical Solutions Ltd.

Israel · Raanana · www.inovytec.com
✓ Record-verifiedregistrations found in 7 marketsEU SRN IL-MF-000034055

This company has registrations in European Union, United States, United Kingdom, Brazil, Australia, Israel, Russia — 7 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
24UDI-DI device records
Class I 5Class IIa 11Class IIb 8
USUnited StatesFDA openFDA
3listed device types
Class I 2Class II 1Class III 0
plus 3 registration records and 0 510(k)
UKUnited KingdomMHRA PARD
4registered device records
Class IIa 3Class IIb 1
BRBrazilANVISA
1registered devices
Class I 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
pendingnot queried
KRSouth KoreaMFDS GMP
pendingnot queried
AUAustraliaTGA ARTG
2active ARTG entries
Class I 1IIb 1
HKHong KongMDACS
pendingnot queried
ILIsraelAMAR
5registrations
RURussiaRoszdravnadzor
1active registrations
Class 2b 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 Union24 raw hits, 0 excluded, 24 confirmed
United States3 registration records, 0 510(k), 0 PMA
United Kingdom4 confirmed, 0 excluded
Brazil1 confirmed, 0 excluded
Manufacturer names merged into this page: INOVYTEC MEDICAL SOLUTIONS LTD. · INOVYTEC MEDICAL SOLUTION LTD

Regulatory identity

EU manufacturer SRN
IL-MF-000034055
EU authorised representative
Obelis s.a.
UK responsible person
Obelis UK Ltd

Company information

Country
Israel
City
Raanana
Website
www.inovytec.com
Product categories
Clinical Diagnostics & Therapeutic TechnologiesMedical Devices & Clinical EquipmentEmergency, Rescue & Disaster Medicine

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

Orthosis, Cervical 1Set, Tubing And Support, Ventilator (W Harness) 1Ventilator, Continuous, Facility Use 1

Registration details (sample)

MarketIdentifierNameClass / date
EU07290017096735VentwayClass IIb
EU07290017096759VentwayClass IIb
EU07290017096742VentwayClass IIb
EU07290017096728VentwayClass IIb
UK63534Ventway SparrowClass IIa
UK44225Ventway SparrowClass IIa
UK44225Ventway SparrowClass IIa
BR80921090002Lubo Airway CollarClass I

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