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HMC Premedical S.p.A.

Italy · Mirandola (MO) · www.hmcgroup.com

✓ Record-verifiedregistrations found in 6 marketsEU SRN IT-MF-000029438

This company has registrations in European Union, United States, United Kingdom, Brazil, Australia, 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

162UDI-DI device records

Class I 14Class IIa 49Class IIb 99

USUnited StatesFDA openFDA

5listed device types

Class I 1Class II 4Class III 0

plus 4 registration records and 1 510(k)

UKUnited KingdomMHRA PARD

74registered device records

Class I 8Class IIa 55Class IIb 9System or Procedure Pack 2

BRBrazilANVISA

7registered devices

Class I 2Class II 5

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

pendingnot queried

AUAustraliaTGA ARTG

20active ARTG entries

Class I 3IIa 13IIb 1Class Is (sterile) 3

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.

European Union285 raw hits, 123 excluded, 162 confirmed

United States4 registration records, 1 510(k), 0 PMA

United Kingdom74 confirmed, 0 excluded

Brazil7 confirmed, 0 excluded

Manufacturer names merged into this page: HMC Premedical S.p.A. · HMC Premedical Spa · HMC PREMEDICAL S.P.A

Regulatory identity

EU manufacturer SRN: IT-MF-000029438
UK responsible person: HMC Medical UK Limited

Business registration

LEI: 815600674F149AFD0872
Registration status: Active
Legal form: Società Per Azioni (SPA)
Incorporated: 1998-03-18
Registered address: VIA BOSCO, 1/3, MIRANDOLA, 41037
Registration authority: Business Register, no. 02504130366
Registry record updated: 2026-04-22

Business registration data from GLEIF, retrieved 2026-09-02. Public registry information only; details of directors and shareholders are not collected.

Registration details (sample)

Market	Identifier	Name	Class / date
EU	08057723900195	—	Class IIa
EU	18053676297020	—	Class I
EU	18053676297013	—	Class I
EU	18055162480022	—	Class IIa
UK	46634	HELMET MANOMETER 22F	Class IIa
UK	60882	ADULT DIMAX MASK HEADGEAR (FOR RESTERILIZABLE MASKS)	Class IIa
UK	38569	Blood Administration Set	Class IIa
US	K242917	Enteral Drainage System, Enteral Medicine straw	2025-06-18
BR	10289680155	Adaptador de conexão EN FIT para frascos Medicina	Class I
BR	10289689008	Adaptador de conexão EN FIT para conexão funil Medicina - LK01	Class I
BR	10289680157	Sonda para nutriçao enteral com guia e conexao EN FIT Medicina	Class II

HMC Premedical S.p.A.

Registrations by market

How these numbers were verified

Regulatory identity

Company information

Business registration

FDA 510(k) clearances by year

FDA listed device types

Registration details (sample)

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