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ESR1 (6q25) gene break apart probe reagent

by Oacp Ie Ltd

Ref FP-410

Active European Union

CE IVDD

Valid until

Not listed

EUDAMED holds no validity date

FDA recalls

Not applicable

No FDA record for this device

Documents

None, self-declared

Class I: no certifier involved

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDD NumberB-5391540380FP-410T94Z Basic UDI-DI D-5391540380FP-410T94ZUDI-DIDate21 Dec 2025RegisteredStatusActive

Certificates

0 certificates · EUDAMED

No certifier certificate is listed. Devices of this class are self-declared by the manufacturer.

Coverage

1 jurisdiction

SwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

European Union — CE/IVDD Active

Specification

EUDAMED

Device Name
ESR1 (6q25) gene break apart probe reagent
Model / Reference
FP-410
Primary DI / UDI-DI
D-5391540380FP-410T94Z
Basic UDI-DI
B-5391540380FP-410T94Z
EMDN Code
W01030703 DNA in situ hybridisation reagents
Device Class
Class IVD General
EU market of registration
Italy

Manufacturer details

EUDAMED SRN
IE-MF-000003506

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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