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OMNIA SRL

Italy · Fidenza

✓ Record-verifiedregistrations found in 5 markets

This company has registrations in United States, Canada, Taiwan, Australia, Israel — 5 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

27listed device types

Class I 20Class II 7Class III 0

plus 29 registration records and 3 510(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

0active device licences

7 including historic records

TWTaiwanTFDA

3valid device licences

Class I 3

SGSingaporeHSA SMDR

pendingnot queried

KRSouth KoreaMFDS GMP

pendingnot queried

AUAustraliaTGA ARTG

3active ARTG entries

Class I 1IIa 1Class Is (sterile) 1

HKHong KongMDACS

pendingnot queried

ILIsraelAMAR

7registrations

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 States29 registration records, 3 510(k), 0 PMA, 3 excluded

Manufacturer names merged into this page: OMNIA SRL

FDA 510(k) clearances by year

12011 · K110724

12014 · K132464

12018 · K180630

FDA listed device types

showing 8 of 27

Gown, Surgical 1System, Suction, Lipoplasty 1Suture, Surgical, Nonabsorbable, Expanded, Polytetraflouroethylene 1Mask, Surgical 1Drape, Surgical, Antimicrobial 1Suction Lipoplasty System For Removal And Transfer 1General Surgery Tray 1Cap, Surgical 1

Market	Identifier	Name	Class / date
US	K180630	PTFE SURGICAL SUTURE	2018-04-06
US	K132464	PTFE SURGICAL SUTURE	2014-02-12
US	K110724	SURGICAL PROCEDURE PACKS	2011-06-23

OMNIA SRL

Registrations by market

How these numbers were verified

Company information

FDA 510(k) clearances by year

FDA listed device types

Registration details (sample)

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