Skip to content

VS5258-G

by Versah, LLC

Part of a family of 27 devices: see the family page

Ref VS5258-GModel Densah Bur

VS5258-G is a device classified as Class IIa in the EU and Class I in the US made by Versah, LLC, registered in EUDAMED on 18 Aug 2026 (Basic UDI-DI 0850017652DensahLE) with CE/MDR certificate 1000272589 valid until 12 Aug 2031 and listed in FDA GUDID since 7 Jan 2026 (UDI-DI 00850017652989), active as of 24 Oct 2026.

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

CE MDR

Valid until

12 Aug 2031

CE MDR certificate

FDA recalls

Not checked

No FDA submission to match recalls against

Documents

1 certificate

Certifier DQS Medizinprodukte GmbH

Trust

Unverified

Source EUDAMED, GUDID, synced 24 Oct 2026.

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number1000272589 Date10 Sep 2026IssuedStatusActive expires 12 Aug 2031
United StatesGUDID listing GUDID Number00850017652989 UDI-DI Date7 Jan 2026ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI 0850017652DensahLE registered 18 Aug 2026 Active· +1 more in the status table
  • FDA GUDID UDI-DI 00850017652989 listed 7 Jan 2026 Listed

Certificates

1 certificate · EUDAMED

EUDAMED certificates (1)
  • 1000272589 Active

    Quality management system EU MDR

    Certifier
    DQS Medizinprodukte GmbH 0297
    Issued
    10 Sep 2026
    Expires
    12 Aug 2031

Timeline

4 dated events

  1. Listed FDA GUDID 00850017652989
  2. Registered EUDAMED 0850017652DensahLE
  3. Certificate issued EUDAMED 1000272589
  4. Certificate expires EUDAMED 1000272589

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  • Withdrawn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
VS8 Bur / Densah Bur G4 EUDAMED
VS5258-G GUDID
Generic name
Orthopaedic bur, reusable
Model / reference
VS5258-G, Densah Bur
Primary DI / UDI-DI
00850017652989
Basic UDI-DI
0850017652DensahLE
FDA product code
EJL
EMDN code
L150101 Odontostomatology osteotomes, reusable
GMDN term
Orthopaedic bur, reusable
Device class
Class IIa EUDAMED
Class I GUDID
Regulation number
872.3240
EU registration type
Standard device
EU market of registration
Netherlands
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device classEUDAMED
Class IIa
GUDID
Class I

Device class is stated on each registry's own scale: Class IIa in the EU (EUDAMED), Class I in the US (FDA GUDID). EU and US classes are different schemes, so this is not a disagreement.

Similar devices in this category

Other devices filed under ODONTOSTOMATOLOGY OSTEOTOMES, REUSABLE.

Other devices from Versah, LLC

  • Densah Bur Holder VBLK

    Class I

  • VT1525-G

    Class I

  • VT4555-Gs

    Class I

  • VT1525-Gs

    Class I

See all devices from Versah, LLC →

Properties

  • Single use
  • Prescription use
  • Premarket exempt
  • Lot / batch number
  • Manufacturing date
Other properties (20, all answered No)