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Pulse Brown DT 38-6 w/Reinforcement Strip

by Alps South, LLC EUDAMED

Active European Union

Ref CLBNDT38-6

Regulatory status

as of 27 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number07139801000102475 Basic UDI-DIDate10 Feb 2025RegisteredStatusActive

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/MDR Active

Certificates: none listed in EUDAMED

Specification

EUDAMED

Device Name
Tenax & Pulse Liner
Model / Reference
CLBNDT38-6
Primary DI / UDI-DI
00713980038597
Basic UDI-DI
07139801000102475
EMDN Code
Y062499 Lower extremity prostheses - other
Device Class
Class I
Market of Registration
Italy

Manufacturer details

EUDAMED SRN
US-MF-000001260
Authorised representative
AR Experts B.V. NL-AR-000023989

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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