Skip to content

Master-Aid Ortesi Flessibile Pollice

by PIETRASANTA PHARMA S.p.A. 3 variants

Ref 385.57

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 23 Oct 2026. What this means

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number803295614Y060613ZJ Basic UDI-DIDate25 Sep 2026RegisteredStatusActive

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  • Withdrawn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

Device Name
Tutore Elastico E Flessibile per Polso E Pollice
Model / Reference
385.57
Primary DI / UDI-DI
08032956145896
Basic UDI-DI
803295614Y060613ZJ
EMDN Code
Y060613 Wrist-hand-fingers orthoses
Device Class
Class I
Market of Registration
Italy

Manufacturer details

EUDAMED SRN
IT-MF-000018175

Other devices from PIETRASANTA PHARMA S.p.A.

See all devices from PIETRASANTA PHARMA S.p.A. →

Properties

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