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Opthaem System

by Project Engineering srl 2 variants

Ref 10V-08OPT12E-0PModel Endless / On Demand

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 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/MDR Number805750245OPTHSYSYM Basic UDI-DI 18057502450160UDI-DIDate16 Jun 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  • Withdrawn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/MDR Active

Specification

EUDAMED

Model / Reference
Endless / On Demand, 10V-08OPT12E-0P
Primary DI / UDI-DI
18057502450160
Basic UDI-DI
805750245OPTHSYSYM
EMDN Code
Z1203020202 Transportable/portable multi–parameter patient monitors
Device Class
Class IIb
Medical Purpose
Active portable non-invasive monitoring device used to continuously survey vital parameters related to the patient’s hemodynamic profile in real time.

Manufacturer details

EUDAMED SRN
IT-PR-000051906

Other devices from Project Engineering srl

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    Class IIb

  • Opthaem System

    Class IIb

  • Opthaem

    Class IIb

  • MostCareUp

    Class IIb

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    Class IIb

  • Opthaem

    Class IIb

See all devices from Project Engineering srl →

Properties

Other properties (1)

  • Sterile: No