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BANDANA vollelastisch

by Werkmeister GmbH + Co. KG 4 variants

Ref 13KZ

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 25 Oct 2026. What this means

Regulatory status

as of registry sync 25 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  • Withdrawn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
13KZ
Primary DI / UDI-DI
04048486073312, 04048486073305, 04048486073374, 04048486073275, 04048486073336, 04048486073282, 04048486073329, 04048486073343, 04048486073299, 04048486073350, 04048486073367
Basic UDI-DI
4048486231101YC
Direct Marketing DI
04048486073312
04048486073305
04048486073374
04048486073275
04048486073336
04048486073282
04048486073329
04048486073343
04048486073299
04048486073350
04048486073367
EMDN Code
Y060499 Abdominal orthoses - other
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