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SpaceOAR Vue™

by Boston Scientific Corporation 2 variants

Ref SO-1010

SpaceOAR Vue™ (SO-1010) is a Class III device made by Boston Scientific, registered in EUDAMED on 17 Jul 2026 (Basic UDI-DI 01915060000000000000279NH), active as of 7 Nov 2026.

Active European Union

CE MDR

Valid until

28 May 2030

CE MDR certificate

FDA recalls

Not applicable

No FDA record for this device

Documents

1 certificate

Certifier DEKRA Certification B.V.

Trust

Unverified

Source EUDAMED, synced 7 Nov 2026.

Regulatory status

as of registry sync 7 Nov 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number01915060000000000000279NH Basic UDI-DI 00864661000157UDI-DIDate17 Jul 2026RegisteredStatusActive

Official records

  • EUDAMED public site Basic UDI-DI 01915060000000000000279NH — open Devices and search for it

Certificates

1 certificate · EUDAMED

EUDAMED certificates (1)
  • 3827895TD12 Active

    Technical documentation EU MDR

    Certifier
    DEKRA Certification B.V. 0344
    Issued
    28 May 2025
    Expires
    28 May 2030

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/MDR Active

Specification

EUDAMED

Device name
SpaceOAR System
Model / reference
SO-1010
Primary DI / UDI-DI
00864661000157
Basic UDI-DI
01915060000000000000279NH
EMDN code
P9005 Implantable spacers for protection during radiation therapy
Device class
Class III
EU registration type
Standard device
EU market of registration
Netherlands

Manufacturer details

EUDAMED SRN
US-MF-000004702
Authorised representative
Boston Scientific Limited IE-AR-000003840

Other devices from Boston Scientific

See all devices from Boston Scientific →

Properties

  • Supplied sterile
  • Implantable
  • Contains CMR substances (carcinogenic, mutagenic or toxic to reproduction)
Other properties (11, all answered No)