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F.L. MEDICAL S.R.L. UNIPERSONALE

Italy · Torreglia Padova

✓ Record-verifiedregistrations found in 4 markets

This company has registrations in United States, Brazil, Saudi Arabia, Israel — 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

5listed device types

Class I 5Class II 0Class III 0

plus 5 registration records and 0 510(k)

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

8registered devices

Class I 8

this export covers Class I / II only (the cadastro route)

SASaudi ArabiaSFDA

4registered 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

pendingnot queried

HKHong KongMDACS

pendingnot queried

ILIsraelAMAR

3registrations

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 States5 registration records, 0 510(k), 0 PMA, 5 excluded

Brazil8 confirmed, 1 excluded

Saudi Arabia4 confirmed, 3 excluded

Manufacturer names merged into this page: F.L. MEDICAL S.R.L. UNIPERSONALE · FL MEDICAL SRL · FL Medical srl Unipersonale · F L Medical s r l Unipersonale

FDA listed device types

Device, General Purpose, Microbiology, Diagnostic 1Container, Specimen, Sterile 1Container, Specimen, Non-Sterile 1Micro Pipette 1Equipment, Laboratory, General Purpose, Labeled Or Promoted For A Specific Medical Use 1

Registration details (sample)

Market	Identifier	Name	Class / date
BR	80788620027	Família de Tubos para Coleta de Sangue Vacumed®	Class I
BR	80788620028	Família de Tubos para Coleta de Urina Vacumed®	Class I
BR	80788620029	Família de Tubos de Ensaio para Coleta de Sangue	Class I
SA	ME0000009134SFDAA00001	VACUMED DISPOSABLE TOURNIQUET LATEX FREE LIGHT BLUE COLOUR 25 pcs	—
SA	ME0000009134SFDAA00002	VACUMED TOURNIQUET WITH SAFETY CLOSURE SYSTEM	—

F.L. MEDICAL S.R.L. UNIPERSONALE

Registrations by market

How these numbers were verified

Company information

FDA listed device types

Registration details (sample)

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