Skip to content

Setablu

by Eurosirel Spa

Ref RCT596323, PCL167535

Active European Union

CE MDR

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/MDR Number8017990RCYJA Basic UDI-DIDate26 Jan 2024RegisteredStatusActive

Certificates

0 certificates · EUDAMED

No notified-body 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  • Withdrawn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/MDR Active

Specification

EUDAMED

Trade Name
Setablu
Setablu - paracalli tondi lattice
Device Name
Cloth Roll
Protective Plaster for Calluses
Model / Reference
RCT596323, PCL167535
Primary DI / UDI-DI
08059174596323, 08055348167535
Basic UDI-DI
8017990RCYJA, 8017990PCLH6
EMDN Code
M050101, M0599
Device Class
Class I
Market of Registration
Italy

Manufacturer details

EUDAMED SRN
IT-MF-000005982

Other devices from Eurosirel Spa

See all devices from Eurosirel Spa →

Properties

  • Contains Latex NoEUDAMEDYesEUDAMED

Other properties (12)

  • Sterile: No
  • Implantable: No
  • Reusable: 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