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MAC1

by Optima Molliter SRL 121 variants

Ref C1D-SOFLEXBVITELLONERO40Model MAC

MAC1 (C1D-SOFLEXBVITELLONERO40) is a Class I device made by Optima Molliter SRL, registered in EUDAMED on 14 Nov 2025 (Basic UDI-DI 805715830MACKP), active as of 24 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 24 Oct 2026.

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number805715830MACKP Basic UDI-DI 08053172154400UDI-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  • Withdrawn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, C1D-SOFLEXBVITELLONERO40
Primary DI / UDI-DI
08053172154400
Basic UDI-DI
805715830MACKP
Direct marketing DI
08053172154400
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

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Properties

Other properties (14, all answered No)