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Herniatome

by Adria S.r.l. 21 variants

Ref 5091435

Active European Union

CE MDR

Valid until

15 Jan 2031

CE MDR certificate

FDA recalls

Not applicable

No FDA record for this device

Documents

1 certificate

Certifier ICIM S.P.A.

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 Number803373711K0299VX Basic UDI-DI 08053175000025UDI-DIDate22 May 2026RegisteredStatusActive

Certificates

1 certificate · EUDAMED

EUDAMED certificates (1)
  • 0425-MDR-030171-00 Active

    Quality management system EU MDR

    Certifier
    ICIM S.P.A. 0425
    Issued
    16 Jan 2026
    Expires
    15 Jan 2031

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/MDR Active

Specification

EUDAMED

Device Name
Devices for percutaneous discectomy and motorized for vertebroplasty / kyphoplasty
Model / Reference
5091435
Primary DI / UDI-DI
08053175000025
Basic UDI-DI
803373711K0299VX
EMDN Code
A01020102 Aspiration fine needles and kits
Device Class
Class IIb
EU market of registration
Italy

Manufacturer details

EUDAMED SRN
IT-MF-000027852

Other devices from Adria S.r.l.

  • Spinertome kit

    Class IIb

  • Spinertome

    Class IIb

  • X-Pander - Direct access kit

    Class IIb

  • Herniatome

    Class IIb

  • Spinertome kit

    Class IIb

  • Spinertome kit

    Class IIb

See all devices from Adria S.r.l. →

Properties

  • Sterile

Other properties (12)

  • 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