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Silima X-Tra

by Thuasne Deutschland GmbH 31 variants

Ref T66377300100B80, T66377301100C80, T66377300300B90, T66377300800B80, T66377300900B20, T66377300700B90, T66377301100B20, T66377300400B20, T66377300400C20, T66377300400C80, T66377300600B20, T66377300900C20, T66377300600C80, T66377301000B80, T66377300800C90, T66377301000C80, T66377300300C80, T66377300500B80, T66377300700C90, T66377301200C80, T66107200401399, T66377300400B80, T66377300400B90, T66377301200C20, T66377300500C90, T66377300700C20, T66377300800C80, T66377300700B20, T66377300500C80, T66377301100C20, T66377300900C90, T66377300300C20, T66377301000C90, T66377301100C90, T66107200301399, T66377300500B20, T66377300500B90

Active European Union

CE MDR

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 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number4035459DE1202B36 Basic UDI-DI Date18 Dec 2025RegisteredStatusActive

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  • Withdrawn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/MDR Active

Specification

EUDAMED

Device Name
Silima X-Tra
Model / Reference
T66377300100B80, T66377301100C80, T66377300300B90, T66377300800B80, T66377300900B20, T66377300700B90, T66377301100B20, T66377300400B20, T66377300400C20, T66377300400C80, T66377300600B20, T66377300900C20, T66377300600C80, T66377301000B80, T66377300800C90, T66377301000C80, T66377300300C80, T66377300500B80, T66377300700C90, T66377301200C80, T66107200401399, T66377300400B80, T66377300400B90, T66377301200C20, T66377300500C90, T66377300700C20, T66377300800C80, T66377300700B20, T66377300500C80, T66377301100C20, T66377300900C90, T66377300300C20, T66377301000C90, T66377301100C90, T66107200301399, T66377300500B20, T66377300500B90
Primary DI / UDI-DI
04035459371742, 04035459372312, 04035459371810, 04035459372107, 04035459372152, 04035459372053, 04035459372275, 04035459371858, 04035459371889, 04035459371896, 04035459371971, 04035459372183, 04035459372015, 04035459372220, 04035459372145, 04035459372251, 04035459371834, 04035459371926, 04035459372084, 04035459372343, 04035459371605, 04035459371865, 04035459371872, 04035459372336, 04035459371964, 04035459372060, 04035459372138, 04035459372039, 04035459371957, 04035459372305, 04035459372206, 04035459371827, 04035459372268, 04035459372329, 04035459371599, 04035459371919, 04035459371933
Basic UDI-DI
4035459DE1202B36
Direct Marketing DI
04035459371742
04035459372312
04035459371810
04035459372107
04035459372152
04035459372053
04035459372275
04035459371858
04035459371889
04035459371896
04035459371971
04035459372183
04035459372015
04035459372220
04035459372145
04035459372251
04035459371834
04035459371926
04035459372084
04035459372343
04035459371605
04035459371865
04035459371872
04035459372336
04035459371964
04035459372060
04035459372138
04035459372039
04035459371957
04035459372305
04035459372206
04035459371827
04035459372268
04035459372329
04035459371599
04035459371919
04035459371933
EMDN Code
Y063018 External breast prostheses
Device Class
Class I
EU market of registration
France

Manufacturer details

EUDAMED SRN
DE-MF-000006210

Other devices from Thuasne Deutschland GmbH

See all devices from Thuasne Deutschland GmbH →

Properties

Other properties (13)

  • Sterile: No
  • 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