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Medica S.p.A.

Italy · Medolla (Modena) · www.medica-spa.com

✓ Record-verifiedregistrations found in 9 markets

This company has registrations in United States, United Kingdom, Brazil, Canada, Taiwan, South Korea, Hong Kong, Israel, Russia — 9 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

7listed device types

Class I 1Class II 6Class III 0

plus 18 registration records and 0 510(k)

UKUnited KingdomMHRA PARD

20registered device records

Class I 1Class IIa 2Class IIb 9System or Procedure Pack 8

BRBrazilANVISA

9registered devices

Class I 1Class II 8

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

4 including historic records

TWTaiwanTFDA

8valid device licences

Class I 4Class II 4

SGSingaporeHSA SMDR

pendingnot queried

KRSouth KoreaMFDS GMP

2GMP quality-system certificates

Business type not stated 1Import 1

AUAustraliaTGA ARTG

pendingnot queried

HKHong KongMDACS

4valid listings

Class II 1Class III 3

ILIsraelAMAR

8registrations

RURussiaRoszdravnadzor

1active registrations

Class 2b 1

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 Union732,097 raw hits, 100 excluded, 0 confirmed. Large result set — only the first 300 verified

United States18 registration records, 0 510(k), 0 PMA, 51 excluded

United Kingdom20 confirmed, 1,883 excluded

Brazil9 confirmed, 41 excluded

Saudi Arabia0 confirmed, 7 excluded

Canada0 confirmed, 12 excluded

Manufacturer names merged into this page: Medica S.p.A. · AB MEDICA GROUP S. A. · MEDICA S.P.A. · MEDICA S.P.A · MEDICA S.p.A. · AB MEDICA GROUP, S. A.

Regulatory identity

UK responsible person: Compliance Solutions (Lifesciences) Ltd

Business registration

LEI: 815600FE16FA9F3E2296
Registration status: Active
Legal form: Società Per Azioni (SPA)
Incorporated: 1985-03-05
Registered address: VIA DEGLI ARTIGIANI, 7, MEDOLLA, 41036
Registration authority: Business Register, no. 01604300366
Registry record updated: 2026-08-10

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

FDA listed device types

Device, Cystometric, Hydraulic 1Subsystem, Water Purification 1System, Water Purification, General Medical Use 1Dialyzer, High Permeability With Or Without Sealed Dialysate System 1Pediatric Hemodialysis System 1Hypothermic Machine Perfusion System And Accessories For Orthotopic Liver Transplant 1Recorder, Paper Chart 1

Registration details (sample)

Market	Identifier	Name	Class / date
UK	62789	CAREPAD	Class I
UK	58091	Afersmart Plus kit	System or Procedure Pack
UK	58091	AcuSmart C kit TPE 400	System or Procedure Pack
BR	82926689006	KIT DE LINHA DE SANGUE PEDIÁTRICA UNIVERSAL	Class II
BR	81387399007	Conjunto Hemoconcentrador Série DP de Alta Performance	Class II
BR	82685059001	ExoSmart	Class II