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Motiva Implants

by Establishment Labs 1,000+ variants

Part of a family of 80 devices: see the family page

Ref RVF-355+Model Motiva Implants Round VelvetSurface Plus

Motiva Implants (RVF-355+) is a Class III device made by Establishment Labs, registered in EUDAMED on 5 Nov 2025 (Basic UDI-DI 7445161VelvetPlus62) with CE/MDR certificate MDR 798371 valid until 1 Jan 2030, active as of 24 Oct 2026.

Active European Union

CE MDR

Valid until

1 Jan 2030

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 24 Oct 2026.

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR NumberMDR 798371 Date12 Jun 2026IssuedStatusActive expires 1 Jan 2030

Official records

Certificates

1 certificate · EUDAMED

EUDAMED certificates (1)
  • MDR 798371 Active Supplemented

    Technical documentation EU MDR

    Certifier
    BSI Group The Netherlands B.V. 2797
    Issued
    12 Jun 2026
    Expires
    1 Jan 2030
    Reason
    Change approved

Timeline

3 dated events

  1. Registered EUDAMED 7445161VelvetPlus62
  2. Certificate issued EUDAMED MDR 798371
  3. Certificate expires EUDAMED MDR 798371

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/MDR Active

Specification

EUDAMED

Model / reference
Motiva Implants Round VelvetSurface Plus, RVF-355+
Primary DI / UDI-DI
07445161005304
Basic UDI-DI
7445161VelvetPlus62
EMDN code
P0601010202, X020102
Device class
Class III
EU registration type
Standard device
EU market of registration
Belgium

Manufacturer details

EUDAMED SRN
CR-MF-000008155
Authorised representative
Emergo Europe B.V. NL-AR-000000116

Other devices from Establishment Labs

See all devices from Establishment Labs →

Properties

  • Supplied sterile
  • Implantable
Other properties (12, all answered No)