HomeUSAAzena Medical, LLC

Azena Medical, LLC

USA · Walnut Creek
✓ Record-verifiedregistrations found in 4 markets

This company has registrations in United States, Brazil, Singapore, Australia — 4 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
3listed device types
Class I 0Class II 3Class III 0
plus 4 registration records and 4 510(k)
UKUnited KingdomMHRA PARD
pendingnot queried
BRBrazilANVISA
0registered devices
1 including historic records
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
1device registrations
CLASS C 1
KRSouth KoreaMFDS GMP
pendingnot queried
AUAustraliaTGA ARTG
7active ARTG entries
Class I 5IIb 2
HKHong KongMDACS
pendingnot queried
ILIsraelAMAR
pendingnot queried
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.

United States4 registration records, 4 510(k), 0 PMA
Manufacturer names merged into this page: AZENA MEDICAL · AZENA MEDICAL, LLC

Company information

Country
USA
City
Walnut Creek

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 510(k) clearances by year

12015 · K152032
12020 · K192617
12021 · K210350
12026 · K260765

FDA listed device types

Lamp, Infrared, Therapeutic Heating 1Powered Laser Surgical Instrument 1Laser, Dental, Soft Tissue 1

Registration details (sample)

MarketIdentifierNameClass / date
USK260765Gemini NOVA 810+980 Soft Tissue Laser2026-03-10
USK210350Gemini 2 810+980 Soft Tissue Laser2021-11-18
USK192617Gemini 810+980 Soft Tissue Laser2020-02-20

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