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Digetop

by Levante srl

Ref 2128

Active European Union

CE MDR CE MDD

Valid until

Not listed

EUDAMED holds no validity date

FDA recalls

Not applicable

No FDA record for this device

Documents

None linked in EUDAMED

A group certificate may exist

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 NumberB-DIGETOP3S Basic UDI-DI Date7 Jul 2025RegisteredStatusActive
European UnionCE/MDD NumberB-DIGETOP3S Basic UDI-DI Date7 Jul 2025RegisteredStatusActive

Certificates

0 certificates · EUDAMED

EUDAMED lists no certificate for this device's Basic UDI-DI.

A certificate issued for a device group may exist without being linked here.

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/MDR, CE/MDD Active

Specification

EUDAMED

Model / Reference
2128
Primary DI / UDI-DI
D-DIGETOP3S, 80537821921284
Basic UDI-DI
B-DIGETOP3S, 80537821921284J
Direct Marketing DI
80537821921284
EMDN Code
G0401, G99
Device Class
Class I
Class IIb
EU market of registration
Italy

Manufacturer details

EUDAMED SRN
IT-MF-000036829

Other devices from Levante srl

Properties

  • Contains Latex YesEUDAMEDNoEUDAMED
  • Administering Medicine NoEUDAMEDYesEUDAMED

Other properties (11)

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