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Alignment Device

by Integrum AB

Part of a family of 120 devices: see the family page

Ref 1653

Alignment Device (1653) is a Class IIb device made by Integrum AB, registered in EUDAMED on 8 Oct 2025 (Basic UDI-DI 73401521oprasystemRW), active as of 7 Nov 2026.

Active European Union

CE MDR

Valid until

26 Feb 2028

CE MDR certificate

FDA recalls

Not applicable

No FDA record for this device

Documents

1 certificate

Certifier BSI Group The Netherlands B.V.

Trust

Unverified

Source EUDAMED, synced 7 Nov 2026.

Regulatory status

as of registry sync 7 Nov 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number73401521oprasystemRW Basic UDI-DI 07340152101617UDI-DIDate8 Oct 2025RegisteredStatusActive

Official records

Certificates

1 certificate · EUDAMED

EUDAMED certificates (1)
  • MDR 762797 Active Amended

    Technical documentation EU MDR

    Certifier
    BSI Group The Netherlands B.V. 2797
    Issued
    28 Nov 2025
    Expires
    26 Feb 2028
    Reason
    Other

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/MDR Active

Specification

EUDAMED

Device name
OPRA Implant System
Model / reference
1653
Primary DI / UDI-DI
07340152101617
Basic UDI-DI
73401521oprasystemRW
EMDN code
Y0699 External prostheses and orthoses - other
Device class
Class IIb
EU registration type
Standard device
EU market of registration
Sweden

Manufacturer details

EUDAMED SRN
SE-MF-000026900

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Properties

  • Implantable
Other properties (14, all answered No)