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VT8 Bur / Densah Bur G4

by Versah, LLC 3 variants

Ref VT3848-GSModel Short Densah Burs

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

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 Number1000272589 Date10 Sep 2026IssuedStatusActive expires 12 Aug 2031
United StatesGUDID listing GUDID Number00810212140025 UDI-DI Date7 Jan 2026ListedStatusListed GUDID: in commercial distribution

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

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  • Withdrawn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
VT8 Bur / Densah Bur G4 EUDAMED
VT3848-Gs GUDID
Generic Name
Orthopaedic bur, reusable
Model / Reference
Short Densah Burs, VT3848-GS
Primary DI / UDI-DI
00810212140025
Basic UDI-DI
0850017652DensahS7P
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 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

Manufacturer details

EUDAMED SRN
US-MF-000013239
Authorised representative
Emergo Europe B.V. NL-AR-000000116

Other devices from Versah, LLC

  • Densah Bur Holder VBLK

    Class I

  • VT1525-G

    Class I

  • VT4555-Gs

    Class I

  • VT1525-Gs

    Class I

  • VT4858-G

    Class I

  • VT3545-G

    Class I

See all devices from Versah, LLC →

Properties

  • Single Use
  • Prescription Use
  • Premarket Exempt
  • Lot / Batch Number
  • Manufacturing Date

Other properties (19)

  • Sterile: No
  • 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
  • Expiration Date: No