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Easynject

by Biopsybell SRL 2 variants

Ref KVTGUN-DS1

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

CE MDR CE MDD

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
European UnionCE/MDD EUDAMED Number8033860KYPFT05A1S3Z Basic UDI-DI 08033860036584UDI-DIDate20 Jan 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number08033860036584 UDI-DI Date29 Sep 2022ListedStatusListed 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  • IT349638 Withdrawn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  • Withdrawn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/MDD, CE/MDR Active
  • United States GUDID listing Listed

Specification

EUDAMED · GUDID

Trade Name
Easynject EUDAMED
Biopsybell GUDID
Generic Name
Orthopaedic cement preparation/delivery kit
Device Name
Accessories for Bone Augmentation Material Injection
Model / Ref / Catalog
KVTGUN-DS1, EASYNJECT
Primary DI / UDI-DI
08033860036584
Basic UDI-DI
8033860KYPFT05A1S3Z, B-08033860036584
FDA Product Code
OAR
EMDN Code
P099002 Orthopaedic cement preparation and application devices and kits
GMDN Term
Orthopaedic cement preparation/delivery kit
Device Class
Class I
Regulation Number
888.4200
EU market of registration
Italy
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Model / ReferenceEUDAMED
KVTGUN-DS1
GUDID
EASYNJECT

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