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Heka

by Aso LLC United States EUDAMED

Ref VH-OT0198Model 40-3001/ 780349 / 40-3003 / 780351 / 40-3014 / 752825 / 40-3070 / 2003043 / 40-3071 / 2003041 / 40-3075 / 2003042 / 40-4013 / 752892 / 40-6001 / 781429 / 40-6003 / 781430 / 40-6013 / 781431 / 75-1623 / 781623 / 75-4331 / 754331 / 75-4378 / 754378

EMDN M04040301

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number0017276M226M3 Basic UDI-DIDate31 Jan 2024RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Not covered

European Union — CE/MDR Active

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 22 Oct 2026

Device Name
Non-Sterile Hydrocolloid Bandages
Model / Reference
40-3001/ 780349 / 40-3003 / 780351 / 40-3014 / 752825 / 40-3070 / 2003043 / 40-3071 / 2003041 / 40-3075 / 2003042 / 40-4013 / 752892 / 40-6001 / 781429 / 40-6003 / 781430 / 40-6013 / 781431 / 75-1623 / 781623 / 75-4331 / 754331 / 75-4378 / 754378, VH-OT0198
Primary DI / UDI-DI
08715886028872
Basic UDI-DI
0017276M226M3
EMDN Code
M04040301 Hydrocolloid dressings, non-combined
Device Class
Class IIa
Market of Registration
Netherlands

Manufacturer details

EUDAMED SRN
US-MF-000008641
Authorised representative
Aso Europe BV NL-AR-000004377

Other devices from Aso LLC

See all devices from Aso LLC →

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 (1)

  • EUDAMED 698bd88f-5be7-46f9-888c-24c5bf8a7e89 61 fields · synced 22 Oct 2026