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PtoleMedic System

by Lento Medical Innovation, Inc.

Ref PMS-001Model PtoleMedic System

Active European Union

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 23 Oct 2026. What this means

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD NumberB-G283PMS0010 Basic UDI-DI G283PMS0010UDI-DIDate31 Aug 2026RegisteredStatusActive

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  • Withdrawn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/MDD Active

Specification

EUDAMED

Model / Reference
PtoleMedic System, PMS-001
Primary DI / UDI-DI
G283PMS0010
Basic UDI-DI
B-G283PMS0010
EMDN Code
V92 Medical device software - not included in other classes
Device Class
Class IIa
Special Device Type
-1192
EU market of registration
Italy

Manufacturer details

EUDAMED SRN
US-MF-000028244
Authorised representative
MDSS GmbH DE-AR-000005430

Other devices from Lento Medical Innovation, Inc.

Properties

Other properties (11)

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