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Motiva Implants

by Establishment Labs Costa Rica EUDAMED

Ref SZM-310Z, SZF-355Z, SZF-295Z, SZM-185Z, SZF-625Q, SZM-260Z, SZD-265Z, SZF-375Z, SZC-650Z, SZM-275Q, SZC-825Z, SZC-325Q, SZD-525Z, SZM-140Q, SZF-425Q, SZD-215Q, SZD-425Z, SZC-260Z, SZD-575Q, SZD-285Z, SZM-400Z, SZF-315Z, SZF-205Z, SZD-190Q, SZC-350Z, SZM-150Q, SZF-205Q, SZC-550Q, SZD-320Z, SZC-180Q, SZM-525Z, SZF-400Q, SZF-450Z, SZD-380Z, SZC-925Z, SZM-220Z, SZM-170Z, SZM-360Q, SZD-300Q, SZD-180Z, SZF-235Z, SZM-160Z, SZF-700Z, SZD-300Z, SZM-230Z, SZD-425Q, SZF-315Q, SZF-235Q, SZD-625Q, SZC-280Q, SZC-440ZModel Motiva Implants Round Sizers with Zen, Motiva Implants Round Sizers with Qid EMDN P0699

Regulatory status

as of 26 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR NumberMDR 745219 Date12 Jun 2026IssuedStatusWithdrawn No longer placed on the EU market expires 22 May 2027

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not known
  • Not covered

European Union — CE/MDR Withdrawn

Certificates

3 certificates · EUDAMED

EUDAMED certificates (3)
  • MDR 798371 Supplemented

    Technical documentation EU MDR

    Notified body
    Notified body 2797
    Issued
    12 Jun 2026
    Expires
    1 Jan 2030
    Reason
    Change approved
  • MDR 768275 Supplemented

    Technical documentation EU MDR

    Notified body
    Notified body 2797
    Issued
    12 Jun 2026
    Expires
    5 Jan 2028
    Reason
    Change approved
  • 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 · synced 24 Oct 2026

Model / Reference
Motiva Implants Round Sizers with Zen, SZM-310Z, SZF-355Z, SZF-295Z, SZM-185Z, Motiva Implants Round Sizers with Qid, SZF-625Q, SZM-260Z, SZD-265Z, SZF-375Z, SZC-650Z, SZM-275Q, SZC-825Z, SZC-325Q, SZD-525Z, SZM-140Q, SZF-425Q, SZD-215Q, SZD-425Z, SZC-260Z, SZD-575Q, SZD-285Z, SZM-400Z, SZF-315Z, SZF-205Z, SZD-190Q, SZC-350Z, SZM-150Q, SZF-205Q, SZC-550Q, SZD-320Z, SZC-180Q, SZM-525Z, SZF-400Q, SZF-450Z, SZD-380Z, SZC-925Z, SZM-220Z, SZM-170Z, SZM-360Q, SZD-300Q, SZD-180Z, SZF-235Z, SZM-160Z, SZF-700Z, SZD-300Z, SZM-230Z, SZD-425Q, SZF-315Q, SZF-235Q, SZD-625Q, SZC-280Q, SZC-440Z
Primary DI / UDI-DI
07445161019349, 07445161019707, 07445161019677, 07445161019264, 07445161015150, 07445161019318, 07445161019486, 07445161019714, 07445161019950, 07445161014702, 07445161019974, 07445161015242, 07445161019578, 07445161014603, 07445161015112, 07445161014832, 07445161019554, 07445161019837, 07445161014962, 07445161019493, 07445161019363, 07445161019684, 07445161019622, 07445161014818, 07445161019875, 07445161014610, 07445161015006, 07445161015310, 07445161019516, 07445161015181, 07445161019394, 07445161015105, 07445161019745, 07445161019547, 07445161019981, 07445161019288, 07445161019257, 07445161014733, 07445161014887, 07445161019424, 07445161019646, 07445161019240, 07445161019783, 07445161019509, 07445161019295, 07445161014931, 07445161015068, 07445161015020, 07445161014979, 07445161015228, 07445161019905
Basic UDI-DI
7445161RoundsizersZenDE, 7445161RoundsizersQV5
EMDN Code
P0699 Breast implants - other
Device Class
Class IIa

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
Other properties (12)
  • Implantable: No
  • 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 (51)

  • EUDAMED 7a13e70b-79ce-4b1a-963c-215c9be5cade 61 fields · synced 24 Oct 2026
  • EUDAMED 07445161019707|7445161ROUNDSIZERSZENDE 61 fields · synced 16 May 2026
  • EUDAMED 07445161019677|7445161ROUNDSIZERSZENDE 61 fields · synced 16 May 2026
  • EUDAMED 07445161019264|7445161ROUNDSIZERSZENDE 61 fields · synced 16 May 2026
  • EUDAMED 07445161015150|7445161ROUNDSIZERSQV5 61 fields · synced 16 May 2026
  • EUDAMED 07445161019318|7445161ROUNDSIZERSZENDE 61 fields · synced 16 May 2026
  • EUDAMED 07445161019486|7445161ROUNDSIZERSZENDE 61 fields · synced 16 May 2026
  • EUDAMED 07445161019714|7445161ROUNDSIZERSZENDE 61 fields · synced 16 May 2026
  • EUDAMED 07445161019950|7445161ROUNDSIZERSZENDE 61 fields · synced 16 May 2026
  • EUDAMED 07445161014702|7445161ROUNDSIZERSQV5 61 fields · synced 16 May 2026
  • EUDAMED 07445161019974|7445161ROUNDSIZERSZENDE 61 fields · synced 16 May 2026
  • EUDAMED 07445161015242|7445161ROUNDSIZERSQV5 61 fields · synced 16 May 2026
  • EUDAMED 07445161019578|7445161ROUNDSIZERSZENDE 61 fields · synced 16 May 2026
  • EUDAMED 07445161014603|7445161ROUNDSIZERSQV5 61 fields · synced 16 May 2026
  • EUDAMED 07445161015112|7445161ROUNDSIZERSQV5 61 fields · synced 16 May 2026
  • EUDAMED 07445161014832|7445161ROUNDSIZERSQV5 61 fields · synced 17 May 2026
  • EUDAMED 07445161019554|7445161ROUNDSIZERSZENDE 61 fields · synced 17 May 2026
  • EUDAMED 07445161019837|7445161ROUNDSIZERSZENDE 61 fields · synced 17 May 2026
  • EUDAMED 07445161014962|7445161ROUNDSIZERSQV5 61 fields · synced 17 May 2026
  • EUDAMED 07445161019493|7445161ROUNDSIZERSZENDE 61 fields · synced 17 May 2026
  • EUDAMED 07445161019363|7445161ROUNDSIZERSZENDE 61 fields · synced 17 May 2026
  • EUDAMED 07445161019684|7445161ROUNDSIZERSZENDE 61 fields · synced 17 May 2026
  • EUDAMED 07445161019622|7445161ROUNDSIZERSZENDE 61 fields · synced 17 May 2026
  • EUDAMED 07445161014818|7445161ROUNDSIZERSQV5 61 fields · synced 17 May 2026
  • EUDAMED 07445161019875|7445161ROUNDSIZERSZENDE 61 fields · synced 17 May 2026
  • EUDAMED 07445161014610|7445161ROUNDSIZERSQV5 61 fields · synced 17 May 2026
  • EUDAMED 07445161015006|7445161ROUNDSIZERSQV5 61 fields · synced 17 May 2026
  • EUDAMED 07445161015310|7445161ROUNDSIZERSQV5 61 fields · synced 17 May 2026
  • EUDAMED 07445161019516|7445161ROUNDSIZERSZENDE 61 fields · synced 17 May 2026
  • EUDAMED 07445161015181|7445161ROUNDSIZERSQV5 61 fields · synced 17 May 2026
  • EUDAMED 07445161019394|7445161ROUNDSIZERSZENDE 61 fields · synced 17 May 2026
  • EUDAMED 07445161015105|7445161ROUNDSIZERSQV5 61 fields · synced 17 May 2026
  • EUDAMED 07445161019745|7445161ROUNDSIZERSZENDE 61 fields · synced 17 May 2026
  • EUDAMED 07445161019547|7445161ROUNDSIZERSZENDE 61 fields · synced 17 May 2026
  • EUDAMED 07445161019981|7445161ROUNDSIZERSZENDE 61 fields · synced 17 May 2026
  • EUDAMED 07445161019288|7445161ROUNDSIZERSZENDE 61 fields · synced 17 May 2026
  • EUDAMED 07445161019257|7445161ROUNDSIZERSZENDE 61 fields · synced 17 May 2026
  • EUDAMED 07445161014733|7445161ROUNDSIZERSQV5 61 fields · synced 17 May 2026
  • EUDAMED 07445161014887|7445161ROUNDSIZERSQV5 61 fields · synced 18 May 2026
  • EUDAMED 07445161019424|7445161ROUNDSIZERSZENDE 61 fields · synced 18 May 2026
  • EUDAMED 07445161019646|7445161ROUNDSIZERSZENDE 61 fields · synced 18 May 2026
  • EUDAMED 07445161019240|7445161ROUNDSIZERSZENDE 61 fields · synced 18 May 2026
  • EUDAMED 07445161019783|7445161ROUNDSIZERSZENDE 61 fields · synced 18 May 2026
  • EUDAMED 07445161019509|7445161ROUNDSIZERSZENDE 61 fields · synced 18 May 2026
  • EUDAMED 07445161019295|7445161ROUNDSIZERSZENDE 61 fields · synced 18 May 2026
  • EUDAMED 07445161014931|7445161ROUNDSIZERSQV5 61 fields · synced 18 May 2026
  • EUDAMED 07445161015068|7445161ROUNDSIZERSQV5 61 fields · synced 18 May 2026
  • EUDAMED 07445161015020|7445161ROUNDSIZERSQV5 61 fields · synced 18 May 2026
  • EUDAMED 07445161014979|7445161ROUNDSIZERSQV5 61 fields · synced 18 May 2026
  • EUDAMED 07445161015228|7445161ROUNDSIZERSQV5 61 fields · synced 18 May 2026
  • EUDAMED 07445161019905|7445161ROUNDSIZERSZENDE 61 fields · synced 18 May 2026