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Sterimix +

by Societe de Fabrication des Articles Pharmaceutiques SO.F.A.P Ltd Tunisia EUDAMED

Ref AP01-124-99/SO , AP01-224-00/SO, AP01-125-00/SOModel Materiel de réduction des risques de contamination stériles e à usage unique avec filtre antibactérien : STERIMIX+ MAXIMIX+ MAXIMIX DUO+ STERIFILT+ STERIMIX+ DUO , Matériels de réduction des risques de contamination stériles et à usage unique : STERICUP, MAXICUP, STERIMIX , MAXIMIX , STERIFILT FAST, STERIFILT BASIC

EMDN A0499

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number61924931MPRCIIAYD Basic UDI-DIDate16 May 2025RegisteredStatusActive

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
Matériels de réduction des risques de contamination stériles et à usage unique avec filtre antibacterien
Matériels de réduction des risques de contamination
Model / Reference
Materiel de réduction des risques de contamination stériles e à usage unique avec filtre antibactérien : STERIMIX+ MAXIMIX+ MAXIMIX DUO+ STERIFILT+ STERIMIX+ DUO, AP01-124-99/SO, Matériels de réduction des risques de contamination stériles et à usage unique : STERICUP, MAXICUP, STERIMIX, MAXIMIX, STERIFILT FAST, STERIFILT BASIC, AP01-224-00/SO, AP01-125-00/SO
Primary DI / UDI-DI
06192493100283, 06192493101433, 06192493101457
Basic UDI-DI
61924931MPRCIIAYD, 61924931MPRCIST7
EMDN Code
A0499 Solution filters - other
Device Class
Class IIa
Class I
Market of Registration
France

Manufacturer details

EUDAMED SRN
TN-MF-000023623
Authorised representative
Obelis s.a. BE-AR-000000106

Other devices from Societe de Fabrication des Articles Pharmaceutiques SO.F.A.P Ltd

See all devices from Societe de Fabrication des Articles Pharmaceutiques SO.F.A.P Ltd →

Properties & raw data

Show properties, registry sources and raw records
  • Sterile
  • Administering Medicine
Other properties (11)
  • Implantable: No
  • Reusable: No
  • Contains Latex: No
  • Reprocessed: No
  • CMR Substance: No
  • Human-derived: No
  • Human Tissues: No
  • Animal Tissues: No
  • Endocrine Disruptor: No
  • Measuring Function: No
  • Incorporates Medicinal Product: No

Sources (3)

  • EUDAMED bb976da9-afcf-4cca-9df3-5f2790810263 61 fields · synced 22 Oct 2026
  • EUDAMED 06192493101433|61924931MPRCIST7 61 fields · synced 11 May 2026
  • EUDAMED 06192493101457|61924931MPRCIIAYD 61 fields · synced 18 May 2026