EU → North America Device Access

Micromed srl

IT-MF-000009198 · Italy · Roma

Micromed srl is registered in the European database on medical devices as a manufacturer, with 68 devices declared. It has a similarly named entry in the FDA register that we have not verified.

What this manufacturer declares

Class IIb60
Class IIa8

Most frequent device types declared: PDMS, PFCL.

Among these devices, 68 are declared sterile, 60 implantable.

Devices declared under this manufacturer

Showing 12 of 68 declared devices.

Catalogue references include EG-SF6M, MMD-655M, MMD-671O, MMD-672M, MMD-675A, MMD-680.

European nomenclature codes declared: Q02030202, Q02030101, Q02030205.

United States market access

FDA establishment registerSimilar name found — unverified
Matched entryMICROMEDICS, INC. (US) · FDA 2183425
Devices in EUDAMED68
Country of registrationItaly

⚠️ A similar name exists; we do not assert it is the same company — why.

Device-level evidence

Devices with a numeric GTIN68
Found in the U.S. device database0
Share0.0 %

Canadian market access

Health Canada licence listingSimilar name found — unverified
Matched entryMICROMEDICS, INC.

⚠️ A similar name exists; unverified — why.

What it holds in Canada

Licences on record6
Currently active0
Class 2 devices6
First licensed2000-04-10

Licence types: System (3), Single Device (2), Device Group Family (1).

Licensed under: FIBRIJET SURGICAL SEALANT DELIVERY SYSTEM, DUPLOSPRAY MIS SURGICAL SEALANT DELIVERY SYSTE, DUPLOTIP DUAL LUMEN CANNULA, GRAFT DELIVERY DEVICE, ENDOSCOPIC APPLICATOR, GASLESS TIP APPLICATOR.

Notified body certificates

CertificateStatusExpiry
CVD000623issued2028-03-07
CVD000323issued2028-03-07
CSQ0007230223supplemented2028-03-07

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