Skip to content

PRIMA Rehabilitation Accessory Kit

by La Science

Ref RAK001

Active European Union

CE MDR

Valid until

1 Jul 2031

CE MDR certificate

FDA recalls

Not applicable

No FDA record for this device

Documents

2 certificates

Certifier DEKRA Certification B.V.

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, synced 24 Oct 2026. What this means

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number3770030061PRIMAFTKRM Basic UDI-DI 03770030061032UDI-DIDate27 Jul 2026RegisteredStatusActive

Certificates

2 certificates · EUDAMED

EUDAMED certificates (2)
  • 2300953CE01 Active

    Quality management system EU MDR

    Certifier
    DEKRA Certification B.V. 0344
    Issued
    14 Jul 2026
    Expires
    1 Jul 2031
  • 2300953TD01 Active

    Technical documentation EU MDR

    Certifier
    DEKRA Certification B.V. 0344
    Issued
    14 Jul 2026
    Expires
    1 Jul 2031

Coverage

1 jurisdiction

NetherlandsGermanyFranceSpainItaly
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

European Union — CE/MDR Active

  • France
  • Germany
  • Italy
  • Netherlands
  • Spain

Specification

EUDAMED

Device Name
PRIMA Patient Fitting Kit
Model / Reference
RAK001
Primary DI / UDI-DI
03770030061032
Basic UDI-DI
3770030061PRIMAFTKRM
EMDN Code
J0780 Ophthalmological use active implantable devices - accessories
Device Class
Class III
EU market of registration
Germany

Manufacturer details

EUDAMED SRN
FR-MF-000042824

Other devices from La Science

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