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PREMIOFORM Aktivelement 16 mm

by 3TO GmbH Germany EUDAMED

Ref 5130, 5131 EMDN Y061299

Regulatory status

as of 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number42516740050000HT Basic UDI-DIDate23 Apr 2026RegisteredStatusActive

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  • Withdrawn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 · synced 22 Oct 2026

Device Name
Premioform
Model / Reference
5130, 5131
Primary DI / UDI-DI
04251674451308, 04251674451315
Basic UDI-DI
42516740050000HT
EMDN Code
Y061299 Lower extremity orthoses - other
Device Class
Class I
Market of Registration
Germany

Manufacturer details

EUDAMED SRN
DE-MF-000017808

Other devices from 3TO GmbH

See all devices from 3TO GmbH →

Properties & raw data

Show properties, registry sources and raw records
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

Sources (2)

  • EUDAMED dc17259a-aca9-4979-b171-86723cd6d6f9 61 fields · synced 22 Oct 2026
  • EUDAMED 04251674451315|42516740050000HT 61 fields · synced 18 May 2026