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Alfa 10

by Medexim, spol. s r.o. Slovakia EUDAMED

Ref Alfa 10, BTL0001Model Balneological hydromassage device , ALFA 10

EMDN Z120618

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD Number858800918201KK Basic UDI-DIDate24 Mar 2022RegisteredStatusActive
European UnionCE/MDR Number858800918201KK Basic UDI-DIDate24 Mar 2022RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Not covered

European Union — CE/MDD, CE/MDR Active

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 24 Oct 2026

Device Name
Balneological hydromassage device
Balneological hydromassage device BTL-3000
Model / Reference
Balneological hydromassage device, Alfa 10, BTL0001
Primary DI / UDI-DI
08588009182016
Basic UDI-DI
858800918201KK, B-08588009182016
Direct Marketing DI
08588009182016
EMDN Code
Z120618 Hydrogymnastics and hydrotherapy systems
Device Class
Class IIa
Market of Registration
Czechia
Slovakia

Manufacturer details

EUDAMED SRN
SK-MF-000015788

Other devices from Medexim, spol. s r.o.

See all devices from Medexim, spol. s r.o. →

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 9d5760e7-12f2-4f2a-ba1e-cc82f48c5692 61 fields · synced 24 Oct 2026
  • EUDAMED 08588009182016|B-08588009182016 61 fields · synced 24 Oct 2026