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Motiva Implants

by Establishment Labs Costa Rica EUDAMED

Ref E2SM-375ZModel DSM-100Z

EMDN P0601010201,X020102

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number7445161Ergo2ZenBQ Basic UDI-DIDate12 Jun 2023RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Not covered

European Union — CE/MDR Active

Certificates

1 certificate · EUDAMED

EUDAMED certificates (1)
  • MDR 768275 Supplemented

    Technical documentation EU MDR

    Notified body
    Notified body 2797
    Issued
    12 Jun 2026
    Expires
    5 Jan 2028
    Reason
    Change approved

Specification

EUDAMED · synced 24 Oct 2026

Device Name
Motiva Ergonomix2 Diamond , Sterile Silicone Breast Implants - Mini with Zen 100cc - S
Model / Reference
DSM-100Z, E2SM-375Z
Primary DI / UDI-DI
07445161020161
Basic UDI-DI
7445161Ergo2ZenBQ
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 & raw data

Show properties, registry sources and raw records
  • 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

Sources (1)

  • EUDAMED 07445161020161|7445161ERGO2ZENBQ 61 fields · synced 24 Oct 2026