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Motiva Implants

by Establishment Labs EUDAMED

Active European Union

Ref ERSF-400ZModel ERSM-105Z

Regulatory status

as of 27 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR NumberMDR 745219 Date12 Jun 2026IssuedStatusActive expires 22 May 2027

Coverage

1 jurisdiction

NorwayNorwayIcelandNorwaySwedenFinlandFinlandNorwaySwedenFinlandFinlandNorwaySwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceLiechtensteinAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalyTürkiyeTürkiyeSpainSpainCroatiaGreeceTürkiyeTürkiyeTürkiyeTürkiyeMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not known
  • Not covered

European Union — CE/MDR Active

EU market availability

Made available in 32 countries, as listed in EUDAMED:

Declared by the manufacturer in EUDAMED for this device version; may not cover every market.

  • Austria since 23 May 2022
  • Belgium since 23 May 2022
  • Bulgaria since 23 May 2022
  • Croatia since 23 May 2022
  • Cyprus since 23 May 2022
  • Czechia since 23 May 2022
  • Denmark since 23 May 2022
  • Estonia since 23 May 2022
  • Finland since 23 May 2022
  • France since 23 May 2022
  • Germany since 23 May 2022
  • Greece since 23 May 2022
  • Hungary since 23 May 2022
  • Iceland since 23 May 2022
  • Ireland since 23 May 2022
  • Italy since 23 May 2022
  • Latvia since 23 May 2022
  • Liechtenstein since 23 May 2022
  • Lithuania since 23 May 2022
  • Luxembourg since 23 May 2022
  • Malta since 23 May 2022
  • Netherlands since 23 May 2022
  • Northern Ireland since 23 May 2022
  • Norway since 23 May 2022
  • Poland since 23 May 2022
  • Portugal since 23 May 2022
  • Romania since 23 May 2022
  • Slovakia since 23 May 2022
  • Slovenia since 23 May 2022
  • Spain since 23 May 2022
  • Sweden since 23 May 2022
  • Türkiye since 23 May 2022

Last checked 25 Oct 2026.

Certificates

1 certificate · EUDAMED

EUDAMED certificates (1)
  • MDR 745219 Supplemented

    Technical documentation EU MDR

    Notified body
    Notified body 2797
    Issued
    12 Jun 2026
    Expires
    22 May 2027
    Reason
    Change approved

Specification

EUDAMED

Device Name
Breast Implant Round - Mini with Qid Ergonomix 105 cc - S
Model / Reference
ERSM-105Z, ERSF-400Z
Primary DI / UDI-DI
07445161008589
Basic UDI-DI
7445161ErgoroundZen8Y
EMDN Code
P0601010201,X020102
Device Class
Class III
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

  • Sterile
  • Implantable

Other properties (11)

  • 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