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MAC2

by Optima Molliter SRL 154 variants

Ref C2U-SPRINTERVITELLONERO46, C2U-DINOTESSUTOBLU NOTTE43, C2U-RUNNERRCROSTATORBA45, C2U-RACINGNABUKBLU NOTTE42, C2U-RACINGNABUKTESTA DI MORO43, C2D-RUFLEXVITELLONERO38, C2U-TRONKIVITELLONERO44, C2U-SPRINTERVITELLOSALVIA44, C2D-SOFLEXBVITELLONERO39, C2U-RACINGNABUKBLU NOTTE44, C2U-DINOTESSUTOBLU NOTTE42, C2U-JUMPCROSTANERO42, C2U-DINOTESSUTONERO45, C2U-WALKERVITELLOBLU NOTTE43, C2U-RAFFAELEVITELLONERO41, C2U-RAFFAELEVITELLONERO40, C2D-SOFLEXBVITELLONERO37, C2U-PUMPCROSTATESTA DI MORO46, C2U-RACINGNABUKTESTA DI MORO46, C2D-TIZIANACROSTABLU NOTTE36, C2U-TAURUSVITELLONERO41, C2D-TIZIANANAPPABEIGE36, C2U-WALKERVITELLONERO44, C2D-TIZIANANAPPABEIGE40, C2U-WALKERTESSUTOGRIGIO41, C2U-PUMPCROSTANERO45, C2U-GIORGIORVITELLONERO43, C2D-FANNYCROSTAGRIGIO CHIARO41, C2U-RUNNERRCROSTASALVIA41, C2U-TAURUSVITELLONERO46, C2U-WALKERVITELLOBLU NOTTE40, C2D-FANNYNAPPAGRIGIO PERLA41, C2U-TAURUSVITELLONERO43, C2U-RACINGTESSUTOGRIGIO44, C2D-FANNYNAPPAGRIGIO PERLA37, C2U-JUMPCROSTATESTA DI MORO43, C2U-LUTEROVITELLONERO42, C2U-FLEXYVITELLONERO47, C2U-FLEXYVITELLONERO42, C2U-RAFFAELEVITELLONERO46, C2U-DINOCROSTATORTORA43, C2U-WALKERVITELLOTESTA DI MORO44, C2U-RACINGNABUKBLU NOTTE43, C2U-SPRINTERTESSUTOGRIGIO41, C2U-WALKERVITELLOSALVIA44, C2D-RUFLEXVITELLONERO41, C2D-RUFLEXVITELLONERO39, C2U-RUNNERRCROSTATORBA41, C2U-WALKERTESSUTOGRIGIO43Model MAC

Active European Union

CE MDR

Valid until

Not listed

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

Registry data, not yet checked by deviCERTS. Source EUDAMED, synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number805715830MACKP Basic UDI-DI Date14 Nov 2025RegisteredStatusActive

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  • Withdrawn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, C2U-SPRINTERVITELLONERO46, C2U-DINOTESSUTOBLU NOTTE43, C2U-RUNNERRCROSTATORBA45, C2U-RACINGNABUKBLU NOTTE42, C2U-RACINGNABUKTESTA DI MORO43, C2D-RUFLEXVITELLONERO38, C2U-TRONKIVITELLONERO44, C2U-SPRINTERVITELLOSALVIA44, C2D-SOFLEXBVITELLONERO39, C2U-RACINGNABUKBLU NOTTE44, C2U-DINOTESSUTOBLU NOTTE42, C2U-JUMPCROSTANERO42, C2U-DINOTESSUTONERO45, C2U-WALKERVITELLOBLU NOTTE43, C2U-RAFFAELEVITELLONERO41, C2U-RAFFAELEVITELLONERO40, C2D-SOFLEXBVITELLONERO37, C2U-PUMPCROSTATESTA DI MORO46, C2U-RACINGNABUKTESTA DI MORO46, C2D-TIZIANACROSTABLU NOTTE36, C2U-TAURUSVITELLONERO41, C2D-TIZIANANAPPABEIGE36, C2U-WALKERVITELLONERO44, C2D-TIZIANANAPPABEIGE40, C2U-WALKERTESSUTOGRIGIO41, C2U-PUMPCROSTANERO45, C2U-GIORGIORVITELLONERO43, C2D-FANNYCROSTAGRIGIO CHIARO41, C2U-RUNNERRCROSTASALVIA41, C2U-TAURUSVITELLONERO46, C2U-WALKERVITELLOBLU NOTTE40, C2D-FANNYNAPPAGRIGIO PERLA41, C2U-TAURUSVITELLONERO43, C2U-RACINGTESSUTOGRIGIO44, C2D-FANNYNAPPAGRIGIO PERLA37, C2U-JUMPCROSTATESTA DI MORO43, C2U-LUTEROVITELLONERO42, C2U-FLEXYVITELLONERO47, C2U-FLEXYVITELLONERO42, C2U-RAFFAELEVITELLONERO46, C2U-DINOCROSTATORTORA43, C2U-WALKERVITELLOTESTA DI MORO44, C2U-RACINGNABUKBLU NOTTE43, C2U-SPRINTERTESSUTOGRIGIO41, C2U-WALKERVITELLOSALVIA44, C2D-RUFLEXVITELLONERO41, C2D-RUFLEXVITELLONERO39, C2U-RUNNERRCROSTATORBA41, C2U-WALKERTESSUTOGRIGIO43
Primary DI / UDI-DI
08052211768066, 08052211766550, 08054794786741, 08057158308085, 08054794783726, 08057158304209, 08057158307972, 08052211768110, 08057158303202, 08057158308108, 08052211766604, 08054794782576, 08052211766635, 08052211768394, 08057158304551, 08057158304544, 08057158303189, 08054794784518, 08054794783757, 08052211766222, 08057158304322, 08052211766291, 08052211768462, 08052211766338, 08052211768318, 08054794782750, 08052211766925, 08052211765850, 08054794784761, 08057158304377, 08052211768363, 08052211765928, 08057158304346, 08054794785669, 08052211765881, 08054794782682, 08057158307651, 08057158303547, 08057158303493, 08057158304605, 08052211766512, 08052211768608, 08057158308092, 08052211766819, 08057158303349, 08052211767960, 08052211768561, 08057158304230, 08057158304216, 08054794786697, 08052211768332
Basic UDI-DI
805715830MACKP
Direct Marketing DI
08052211768066
08052211766550
08054794786741
08057158308085
08054794783726
08057158304209
08057158307972
08052211768110
08057158303202
08057158308108
08052211766604
08054794782576
08052211766635
08052211768394
08057158304551
08057158304544
08057158303189
08054794784518
08054794783757
08052211766222
08057158304322
08052211766291
08052211768462
08052211766338
08052211768318
08054794782750
08052211766925
08052211765850
08054794784761
08057158304377
08052211768363
08052211765928
08057158304346
08054794785669
08052211765881
08054794782682
08057158307651
08057158303547
08057158303493
08057158304605
08052211766512
08052211768608
08057158308092
08052211766819
08057158303349
08052211767960
08052211768561
08057158304230
08057158304216
08054794786697
08052211768332
EMDN Code
Y063303 Ready-made orthotic shoes
Device Class
Class I
EU market of registration
Italy

Manufacturer details

EUDAMED SRN
IT-MF-000022195

Other devices from Optima Molliter SRL

See all devices from Optima Molliter SRL →

Properties

Other properties (13)

  • Sterile: No
  • Implantable: No
  • Reusable: No
  • Contains Latex: No
  • Reprocessed: No
  • CMR Substance: No
  • Human-derived: No
  • Human Tissues: No
  • Animal Tissues: No
  • Endocrine Disruptor: No
  • Administering Medicine: No
  • Measuring Function: No
  • Incorporates Medicinal Product: No