Skip to content

Atf

by Arya Teb Firouz Co. Iran EUDAMED

Ref PRCA0010Model AVISA 100 EMDN Z12099007

Regulatory status

as of 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number0626349AVISA100UN Basic UDI-DIDate21 Dec 2024RegisteredStatusActive

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  • Withdrawn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 25 Oct 2026

Device Name
Portable RO Water Purifier
Model / Reference
AVISA 100, PRCA0010
Primary DI / UDI-DI
00626349000039
Basic UDI-DI
0626349AVISA100UN
Direct Marketing DI
00626349000039
EMDN Code
Z12099007 Dialysis water treatment systems
Device Class
Class IIa
Market of Registration
Italy

Manufacturer details

EUDAMED SRN
IR-MF-000041973
Authorised representative
Health Tec srl IT-AR-000041308

Other devices from Arya Teb Firouz Co.

  • Atf

    Class IIb

  • Atf

    Class I

  • Atf

    Class IIa

Properties & raw data

Show properties, registry sources and raw records
  • Measuring Function
Other properties (12)
  • 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
  • Incorporates Medicinal Product: No

Sources (1)

  • EUDAMED 2b7ce2a0-506d-4f82-8ad5-d259df6fb946 61 fields · synced 25 Oct 2026