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Oftam

by Amp Produtos Terapêuticos Ltda Brazil EUDAMED

Ref 1005 EMDN M040303

Regulatory status

as of 26 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number78970185OFTAM2Y Basic UDI-DIDate31 Aug 2026RegisteredStatusActive

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  • Withdrawn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 24 Oct 2026

Model / Reference
1005
Primary DI / UDI-DI
07897018500492
Basic UDI-DI
78970185OFTAM2Y
EMDN Code
M040303 Orthoptic eye patches
Device Class
Class I
Market of Registration
Spain

Manufacturer details

EUDAMED SRN
BR-MF-000058056
Authorised representative
CMC Medical Devices & Drugs SL ES-AR-000000293

Other devices from Amp Produtos Terapêuticos Ltda

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 07897018500492|78970185OFTAM2Y 61 fields · synced 24 Oct 2026