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Profilm Aftas Bucales (5ml)

by i+Med S.Coop. Spain EUDAMED

Ref PV00071Model Profilm Aftas Bucales (5 ml) EMDN M04040501

Regulatory status

as of 26 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR NumberB-08437015992143 Basic UDI-DIDate30 Nov 2023RegisteredStatusActive
European UnionCE/MDD NumberB-08437015992143 Basic UDI-DIDate30 Nov 2023RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not known
  • Not covered

European Union — CE/MDR, CE/MDD Active

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 22 Oct 2026

Device Name
Profilm Aftas Bucales
Hidrogel para el tratamiento de heridas internas (AFTA1) / Hydrogel for the treatment of internal wounds (AFTA1)
Model / Reference
Profilm Aftas Bucales (5 ml), PV00071
Primary DI / UDI-DI
08437015992143
Basic UDI-DI
B-08437015992143, 8437015992UI0086G
EMDN Code
M04040501 Hydrogel dressings, non-combined
Device Class
Class IIa
Market of Registration
Spain

Manufacturer details

EUDAMED SRN
ES-MF-000008633

Other devices from i+Med S.Coop.

See all devices from i+Med S.Coop. →

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 cf9676ea-6e77-428f-a595-c9fa1e2cb26c 61 fields · synced 22 Oct 2026
  • EUDAMED 08437015992143|8437015992UI0086G 61 fields · synced 17 May 2026