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TruncuTen® Rumpfstützorthese

by Werkmeister GmbH + Co. KG 4 variants

Ref 91001

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 Number4048486231101YC Basic UDI-DI Date1 Sep 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  • Withdrawn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
Rumpfstützorthese
Model / Reference
91001
Primary DI / UDI-DI
04048486047535, 04048486047566, 04048486178123, 04048486048143, 04048486178024, 04048486177966, 04048486047412, 04048486047603, 04048486047924, 04048486048112, 04048486178260, 04048486048129, 04048486047849, 04048486048136, 04048486047764, 04048486047580, 04048486048037, 04048486178086, 04048486178246, 04048486047436, 04048486048150, 04048486047467, 04048486178161, 04048486178093, 04048486178055, 04048486178215, 04048486047979, 04048486047870, 04048486047450, 04048486047719, 04048486048044, 04048486047405, 04048486048051, 04048486178062, 04048486047726, 04048486047542, 04048486178277, 04048486048105, 04048486047610, 04048486047481, 04048486047429, 04048486047955, 04048486048020, 04048486047474, 04048486047443, 04048486047900, 04048486047757, 04048486048075, 04048486047672, 04048486177973, 04048486047917
Basic UDI-DI
4048486231101YC
Direct Marketing DI
04048486047535
04048486047566
04048486178123
04048486048143
04048486178024
04048486177966
04048486047412
04048486047603
04048486047924
04048486048112
04048486178260
04048486048129
04048486047849
04048486048136
04048486047764
04048486047580
04048486048037
04048486178086
04048486178246
04048486047436
04048486048150
04048486047467
04048486178161
04048486178093
04048486178055
04048486178215
04048486047979
04048486047870
04048486047450
04048486047719
04048486048044
04048486047405
04048486048051
04048486178062
04048486047726
04048486047542
04048486178277
04048486048105
04048486047610
04048486047481
04048486047429
04048486047955
04048486048020
04048486047474
04048486047443
04048486047900
04048486047757
04048486048075
04048486047672
04048486177973
04048486047917
EMDN Code
Y060309 Thoracolumbosacral spine orthoses
Device Class
Class I
EU market of registration
Germany

Manufacturer details

EUDAMED SRN
DE-MF-000005120

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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