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V-Steel

by Biopsybell SRL 9 variants

Part of a family of 240 devices: see the family page

Ref 1312VSS

V-Steel (1312VSS) is a Class IIa device made by Biopsybell SRL, registered in EUDAMED on 20 Jan 2026 (Basic UDI-DI 8033860VERTFT05CL) with CE/MDR certificate IT353495 valid until 14 Jun 2031, active as of 23 Oct 2026.

Active European Union

CE MDR

Valid until

14 Jun 2031

CE MDR certificate

FDA recalls

Not applicable

No FDA record for this device

Documents

2 certificates

Certifier BUREAU VERITAS ITALIA S.P.A.

Trust

Unverified

Source EUDAMED, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR NumberIT353495 Date4 Sep 2026IssuedStatusActive expires 14 Jun 2031

Official records

Certificates

2 certificates · EUDAMED

EUDAMED certificates (2)
  • IT353495 Active Amended

    Quality management system EU MDR

    Certifier
    BUREAU VERITAS ITALIA S.P.A. 1370
    Issued
    4 Sep 2026
    Expires
    14 Jun 2031
    Reason
    Other
  • IT349638 Withdrawn

    Quality assurance EU MDR

    Certifier
    BUREAU VERITAS ITALIA S.P.A. 1370
    Issued
    10 Feb 2026
    Expires
    9 Feb 2030
    Reason
    Other

Timeline

5 dated events

  1. Registered EUDAMED 8033860VERTFT05CL
  2. Certificate issued EUDAMED IT349638
  3. Certificate issued EUDAMED IT353495
  4. Certificate expires EUDAMED IT349638
  5. Certificate expires EUDAMED IT353495

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/MDR Active

Specification

EUDAMED

Device name
Vertebroplasty Systems
Model / reference
1312VSS
Primary DI / UDI-DI
08033860051884
Basic UDI-DI
8033860VERTFT05CL
EMDN code
A019011 Intraosseous infusion and vertebroplasty infusion needles and kits
Device class
Class IIa
EU registration type
Standard device
EU market of registration
Italy

Manufacturer details

EUDAMED SRN
IT-MF-000011601

Similar devices in this category

Other devices filed under INTRAOSSEOUS INFUSION AND VERTEBROPLASTY INFUSION NEEDLES AND KITS.

Other devices from Biopsybell SRL

See all devices from Biopsybell SRL →

Properties

  • Supplied sterile
Other properties (13, all answered No)