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Opthaem

by Project Engineering srl 2 variants

Ref 08OPT15EModel On Demand / Endless

Active European Union

CE MDR

Valid until

4 Jun 2031

CE MDR certificate

FDA recalls

Not applicable

No FDA record for this device

Documents

1 certificate

Certifier KIWA CERMET ITALIA S.P.A.

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 Number805750245OPTHGN Basic UDI-DI 08057502450064UDI-DIDate18 Jun 2026RegisteredStatusActive

Certificates

1 certificate · EUDAMED

EUDAMED certificates (1)
  • MDR 00154-A Active

    Quality management system EU MDR

    Certifier
    KIWA CERMET ITALIA S.P.A. 0476
    Issued
    5 Jun 2026
    Expires
    4 Jun 2031

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/MDR Active

Specification

EUDAMED

Model / Reference
On Demand / Endless, 08OPT15E
Primary DI / UDI-DI
08057502450064
Basic UDI-DI
805750245OPTHGN
EMDN Code
Z1203020202 Transportable/portable multi–parameter patient monitors
Device Class
Class IIb
EU market of registration
Italy

Manufacturer details

EUDAMED SRN
IT-MF-000009571

Other devices from Project Engineering srl

See all devices from Project Engineering srl →

Properties

  • Measuring Function

Other properties (12)

  • 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
  • Incorporates Medicinal Product: No