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Elcam Medical Italy S.p.A.

Italy · Carpi (MO) · www.elcam-medical.com

✓ Record-verifiedregistrations found in 3 marketsEU SRN IT-MF-000012119

This company has registrations in European Union, United States, South Korea — 3 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

14UDI-DI device records

Class I 1Class IIa 13

USUnited StatesFDA openFDA

8listed device types

Class I 1Class II 7Class III 0

plus 16 registration records and 0 510(k)

UKUnited KingdomMHRA PARD

0registered device records

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

TWTaiwanTFDA

0valid device licences

SGSingaporeHSA SMDR

pendingnot queried

KRSouth KoreaMFDS GMP

2GMP quality-system certificates

Import 2

AUAustraliaTGA ARTG

pendingnot queried

HKHong KongMDACS

pendingnot queried

ILIsraelAMAR

pendingnot queried

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 Union17 raw hits, 3 excluded, 14 confirmed

United States16 registration records, 0 510(k), 0 PMA, 2 excluded

United Kingdom0 confirmed, 1 excluded

Brazil0 confirmed, 2 excluded

Manufacturer names merged into this page: ELCAM MEDICAL A.C.A.L. · ELCAM MEDICAL ITALY SPA

Regulatory identity

EU manufacturer SRN: IT-MF-000012119

Business registration

Legal name: ELCAM MEDICAL ITALY SPA
LEI: 815600845186F230CF45
Registration status: Active
Legal form: Società Per Azioni (SPA)
Incorporated: 1997-03-11
Registered address: VIA EMILIA ROMAGNA, 15, CARPI, 41012
Registration authority: Business Register, no. 12096350157
Registry record updated: 2025-09-05

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

Set, Tubing, Blood, With And Without Anti-Regurgitation Valve 1Stopcock, I.V. Set 1Syringe, Piston 1Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass 1Set, Administration, Intravascular 1Catheter, Intravascular, Diagnostic 1Transducer, Blood-Pressure, Extravascular 1Adaptor, Catheter 1

Registration details (sample)

Market	Identifier	Name	Class / date
EU	08053323800057	Closed male luer lock cap, white	Class IIa
EU	08053323800088	Closed yellow MLL/FLL cap in blister packaging	Class IIa
EU	08053323800163	Recirc. fll connector with closed cap	Class I
EU	08053323800019	Recirc. fll connector with vented cap	Class IIa

Elcam Medical Italy S.p.A.

Registrations by market

How these numbers were verified

Regulatory identity

Company information

Business registration

FDA listed device types

Registration details (sample)

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