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D7S522/CEP7 (CE-IVD)

by Oacp Ie Ltd EUDAMED

Active European Union

Ref FP-011-2Model FP-011

Regulatory status

as of 26 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDD NumberB-5391540380FP-011-2XPKT Basic UDI-DIDate20 Dec 2025RegisteredStatusActive

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/IVDD Expiring

Certificates: none listed in EUDAMED

Specification

EUDAMED

Device Name
D7S522/CEP7 (CE-IVD)
Model / Reference
FP-011, FP-011-2
Primary DI / UDI-DI
D-5391540380FP-011-2XPKT
Basic UDI-DI
B-5391540380FP-011-2XPKT
EMDN Code
W01030703 DNA in situ hybridisation reagents
Device Class
Class IVD General
Market of Registration
Italy

Manufacturer details

EUDAMED SRN
IE-MF-000003506

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Properties

Show properties
  • Reagent
  • Professional Testing
Other properties (8)
  • Sterile: No
  • Human Tissues: No
  • Animal Tissues: No
  • Microbial Substances: No
  • Self Testing: No
  • Near-Patient Testing: No
  • Companion Diagnostics: No
  • Surgical Instrument: No