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Arsenio

by USM Healthcare Medical Devices Factory Joint Stock Company 4 variants

Ref ARS-LP154R04

Active European Union

CE MDR

Valid until

30 Aug 2031

CE MDR certificate

FDA recalls

Not applicable

No FDA record for this device

Documents

1 certificate

Certifier INSTITUT PRO TESTOVÁNI A CERTIFIKACI, a. s. (INSTITUTE FOR TESTING AND CERTIFICATION) merged with ex-NB 1390

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, synced 24 Oct 2026. What this means

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number26 0279 QR/NB Date31 Aug 2026IssuedStatusActive expires 30 Aug 2031

Certificates

1 certificate · EUDAMED

EUDAMED certificates (1)
  • 26 0279 QR/NB Active

    Quality management system EU MDR

    Certifier
    INSTITUT PRO TESTOVÁNI A CERTIFIKACI, a. s. (INSTITUTE FOR TESTING AND CERTIFICATION) merged with ex-NB 1390 1023
    Issued
    31 Aug 2026
    Expires
    30 Aug 2031

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/MDR Active

Specification

EUDAMED

Device Name
ARSENIO Bone Plates, Bone Screws (Orthopedic and Trauma Implants)
Model / Reference
ARS-LP154R04
Primary DI / UDI-DI
08935253214022
Basic UDI-DI
89352532USM0009W9
EMDN Code
P09120501, P09120502, P09120599
Device Class
Class IIb
EU market of registration
Czechia

Manufacturer details

EUDAMED SRN
VN-MF-000016114
Authorised representative
CMC Medical Devices & Drugs SL ES-AR-000000293

Other devices from USM Healthcare Medical Devices Factory Joint Stock Company

  • Arsenio

    Class IIb

  • Arsenio

    Class IIb

  • Arsenio

    Class IIb

Properties

  • Sterile
  • Implantable
  • Sutures

Other properties (11)

  • 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