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Medax S.R.L Unipersonale

Italy · San Possidonio · www.medax.it

✓ Record-verifiedregistrations found in 6 markets

This company has registrations in United States, United Kingdom, Brazil, South Korea, Hong Kong, Israel — 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

0UDI-DI device records

USUnited StatesFDA openFDA

3listed device types

Class I 1Class II 2Class III 0

plus 7 registration records and 6 510(k)

UKUnited KingdomMHRA PARD

5registered device records

Class IIa 5

BRBrazilANVISA

31registered devices

Class II 31

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

pendingnot queried

SGSingaporeHSA SMDR

pendingnot queried

KRSouth KoreaMFDS GMP

1GMP quality-system certificates

Import 1

AUAustraliaTGA ARTG

pendingnot queried

HKHong KongMDACS

11valid listings

Class II 11

ILIsraelAMAR

2registrations

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.

European Union2 raw hits, 2 excluded, 0 confirmed

United States7 registration records, 6 510(k), 0 PMA

United Kingdom5 confirmed, 1 excluded

Brazil31 confirmed, 1 excluded

Manufacturer names merged into this page: MEDAX S.R.L. UNIPERSONALE · MEDAX SRL UNIPERSONALE · MEDAX Unipersonale S. R. L.

Regulatory identity

UK responsible person: It's Interventional Regulatory Limited

Registration details (sample)

Market	Identifier	Name	Class / date
UK	35886	Fine Needle Aspiration	Class IIa
UK	46350	Biopsy needle mod. HANDLEX	Class IIa
UK	45018	Coaxial needle for MEDONE biopsy needle	Class IIa
US	K192099	MED-I Bone Marrow Aspiration Needle, MED-S Bone Marrow Aspiration Needle, MED-L Bone Marrow Biopsy and Aspiration System, MED-B Bone Marrow Biopsy System, MED-J Bone Marrow Biopsy and Aspiration System	2020-04-02
US	K192101	Medone Ultra, Medextra	2020-04-02
US	K181803	Medax Biopsy Systems III	2018-10-18
BR	80634880051	AGULHA SEMI-AUTOMÁTICA PARA BIÓPSIA COM INTRODUTOR COAXIAL	Class II
BR	80634880052	AGULHA PARA BIÓPSIA DE TECIDO MOLE COM INTRODUTOR COAXIAL	Class II
BR	80634880030	AGULHA PARA BIÓPSIA HEPÁTICA MEDAX	Class II

Medax S.R.L Unipersonale

Registrations by market

How these numbers were verified

Regulatory identity

Company information

FDA 510(k) clearances by year

FDA listed device types

Registration details (sample)

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