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AKTIVE S.R.L.

Italy · Rome Lazio

✓ Record-verifiedregistrations found in 6 markets

This company has registrations in United States, Brazil, Taiwan, Australia, Israel, Russia — 6 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

10listed device types

Class I 10Class II 0Class III 0

plus 10 registration records and 0 510(k)

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

7registered devices

Class I 3Class II 4

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

1valid device licences

Class II 1

SGSingaporeHSA SMDR

pendingnot queried

KRSouth KoreaMFDS GMP

pendingnot queried

AUAustraliaTGA ARTG

1active ARTG entries

IIa 1

HKHong KongMDACS

pendingnot queried

ILIsraelAMAR

2registrations

RURussiaRoszdravnadzor

5active registrations

Class 1 1Class 2a 4

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 States10 registration records, 0 510(k), 0 PMA

Brazil7 confirmed, 0 excluded

Manufacturer names merged into this page: AKTIVE SRL · AKTIVE S.R.L.

FDA listed device types

showing 8 of 10

Cannula, Trocar, Ophthalmic 1Knife, Ophthalmic 1Spatula, Ophthalmic 1Device, Irrigation, Ocular Surgery 1Cannula, Ophthalmic 1Shield, Eye, Ophthalmic (Including Sunlamp Protective Eyewear And Post-Mydriatic Eyewear) 1Forceps, Ophthalmic 1Clip, Iris Retractor 1

Registration details (sample)

Market	Identifier	Name	Class / date
BR	80443070021	Instrumentos Cirúrgicos Classe I-RI Aktive S.R.L	Class I
BR	80443079012	Instrumentos Cirúrgicos Classe II-RII Aktive S.R.L.	Class II
BR	80443079013	Instrumentos Cirúrgicos Classe II-RVI Aktive S.R.L.	Class II

AKTIVE S.R.L.

Registrations by market

How these numbers were verified

Company information

FDA listed device types

Registration details (sample)

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