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Osteopearl

by Biopsybell SRL 4 variants

Ref 100.432

Active European Union. Also listed in GUDID (US).

CE MDR

Valid until

14 Jun 2031

CE MDR certificate

FDA recalls

Not checked

No FDA submission to match recalls against

Documents

2 certificates

Certifier BUREAU VERITAS ITALIA S.P.A.

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, GUDID, synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED NumberIT353495 Date4 Sep 2026IssuedStatusActive expires 14 Jun 2031
United StatesGUDID listing GUDID Number08033860044893 UDI-DI Date12 Jun 2024ListedStatusListed GUDID: in commercial distribution

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  • IT349638 Withdrawn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

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDR Active
  • United States GUDID listing Listed

Specification

EUDAMED · GUDID

Trade Name
Osteopearl EUDAMED
Biopsybell GUDID
Generic Name
Bone graft delivery kit
Device Name
Kyphoplasty Systems
Model / Ref / Catalog
100.432, OSTEOPEARL™ ACCESS CANNULA & DIAMOND TIP TROCAR 8G
Primary DI / UDI-DI
08033860044893
Basic UDI-DI
8033860KYPFT05A9T, B-08033860044893
FDA Product Code
LXH
EMDN Code
K010301 Spinal percutaneous plastic devices with balloon
GMDN Term
Bone graft delivery kit
Device Class
Class IIa EUDAMED
Class I GUDID
Regulation Number
888.4540
EU market of registration
Italy
GUDID distribution status
In Commercial Distribution
Size
Needle Gauge — 08 Gauge
Length — 120 Millimeter

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Model / ReferenceEUDAMED
100.432
GUDID
OSTEOPEARL™ ACCESS CANNULA & DIAMOND TIP TROCAR 8G
Device ClassEUDAMED
Class IIa
GUDID
Class I

Manufacturer details

EUDAMED SRN
IT-MF-000011601

Other devices from Biopsybell SRL

See all devices from Biopsybell SRL →

Properties

  • Sterile
  • Single Use
  • Prescription Use
  • Premarket Exempt
  • Lot / Batch Number
  • Expiration Date

Other properties (18)

  • 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
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Serial Number: No
  • Manufacturing Date: No