HomeIsraelViora , Ltd.

Viora , Ltd.

Israel · Migdal Haemek
✓ Record-verifiedregistrations found in 8 markets

This company has registrations in United States, Canada, Taiwan, Singapore, South Korea, Australia, Israel, Russia — 8 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
pendingnot queried
USUnited StatesFDA openFDA
9listed device types
Class I 2Class II 7Class III 0
plus 13 registration records and 11 510(k)
UKUnited KingdomMHRA PARD
pendingnot queried
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
1active device licences
Class III 1
7 including historic records
TWTaiwanTFDA
4valid device licences
Class II 4
SGSingaporeHSA SMDR
4device registrations
CLASS B 3CLASS C 1
KRSouth KoreaMFDS GMP
1GMP quality-system certificates
Import 1
AUAustraliaTGA ARTG
3active ARTG entries
IIa 2IIb 1
HKHong KongMDACS
pendingnot queried
ILIsraelAMAR
7registrations
RURussiaRoszdravnadzor
5active registrations
Class 2a 3Class 2b 2
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.

United States13 registration records, 11 510(k), 0 PMA
Canada1 confirmed, 0 excluded
Manufacturer names merged into this page: VIORA LTD. · VIORA, LTD.

Company information

Country
Israel
City
Migdal Haemek

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.

Business registration

Legal name
VIORA LTD
Company number
513726091
Registration status
Active
Incorporated
2005-08-28

Business registration data from Israel Companies Registrar, retrieved 2026-09-02. Public registry information only; details of directors and shareholders are not collected.

FDA 510(k) clearances by year

22009
32014 · K142093
12015 · K150035
22016 · K162363
32020 · K202247

FDA listed device types

showing 8 of 9
Massager, Therapeutic, Electric 1Dermatome 1Powered Light Based Non-Laser Surgical Instrument With Thermal Effect 1Lamp, Infrared, Therapeutic Heating 1Electrosurgical, Cutting & Coagulation & Accessories 1Massager, Vacuum, Light Induced Heating 1Massager, Vacuum, Radio Frequency Induced Heat 1Powered Laser Surgical Instrument 1

Registration details (sample)

MarketIdentifierNameClass / date
USK202247V30 system, V20 system, V10 system, V-VR Hand piece2020-12-09
USK201064V30 System, V20 System, V10 System, V-FR Handpiece2020-07-15
USK200468V30 system, V20 system, V10 system, V-FC Handpiece2020-05-21
CA81275TRIOS (PULSED LIGHT DEVICE)Class III

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