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Bolero Orthopedique

by Groupe Sober SAS

Ref BOLERO ORTHOPEDIQUEModel ORTHESE DE RETROPULSION EPAULE

Active European Union

CE MDD

Valid until

Not listed

EUDAMED holds no validity date

FDA recalls

Not applicable

No FDA record for this device

Documents

None, self-declared

Class I: no certifier involved

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, synced 25 Oct 2026. What this means

Regulatory status

as of registry sync 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD NumberB-03701459802586 Basic UDI-DI Date21 Jul 2026RegisteredStatusActive

Certificates

0 certificates · EUDAMED

No certifier certificate is listed. Devices of this class are self-declared by the manufacturer.

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/MDD Active

Specification

EUDAMED

Model / Reference
ORTHESE DE RETROPULSION EPAULE, BOLERO ORTHOPEDIQUE
Primary DI / UDI-DI
03701459802586, 03701459802616, 03701459802593, 03701459802609, 03701459802579, 03701459802623
Basic UDI-DI
B-03701459802586, B-03701459802616, B-03701459802593, B-03701459802609, B-03701459802579, B-03701459802623
EMDN Code
M030501 Immobilisation bandages for shoulder, arm and collarbone
Device Class
Class I
EU market of registration
France

Manufacturer details

EUDAMED SRN
FR-MF-000017818

Other devices from Groupe Sober SAS

See all devices from Groupe Sober SAS →

Properties

Other properties (11)

  • Sterile: No
  • Implantable: No
  • Reusable: No
  • Contains Latex: No
  • Reprocessed: No
  • Human-derived: No
  • Human Tissues: No
  • Animal Tissues: No
  • Administering Medicine: No
  • Measuring Function: No
  • Incorporates Medicinal Product: No