Skip to content

MAC3

by Optima Molliter SRL 163 variants

Part of a family of 438 devices: see the family page

Ref C3D-SOLEPELLAME RETEGRIGIO CHIARO41Model MAC

MAC3 is a Class I device made by Optima Molliter SRL, registered in EUDAMED on 14 Nov 2025 (Basic UDI-DI 805715830MACKP), active as of 23 Oct 2026.

Active European Union

CE MDR

Valid until

No date given

EUDAMED holds no validity date

FDA recalls

Not applicable

No FDA record for this device

Documents

None, self-declared

Class I: no certifier involved

Trust

Unverified

Source EUDAMED, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number805715830MACKP Basic UDI-DI 08052211764839UDI-DIDate14 Nov 2025RegisteredStatusActive

Official records

Certificates

0 certificates · EUDAMED

No certifier certificate is listed. Devices of this class are self-declared by the manufacturer.

Coverage

1 jurisdiction

SwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

European Union — CE/MDR Active

Specification

EUDAMED

Device name
Mac
Model / reference
MAC, C3D-SOLEPELLAME RETEGRIGIO CHIARO41
Primary DI / UDI-DI
08052211764839
Basic UDI-DI
805715830MACKP
Direct marketing DI
08052211764839
EMDN code
Y063303 Ready-made orthotic shoes
Device class
Class I
EU registration type
Standard device
EU market of registration
Italy

Manufacturer details

EUDAMED SRN
IT-MF-000022195

Similar devices in this category

Other devices filed under EXTERNAL PROSTHESES AND ORTHOSES.

Other devices from Optima Molliter SRL

See all devices from Optima Molliter SRL →

Properties

Other properties (14, all answered No)