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Stahlbohrer

by Edenta Etablissement 99 variants

Ref 36.204.006Model 10521

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

CE MDR

Valid until

26 Mar 2030

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 Number1000183128 Date27 Mar 2025IssuedStatusActive expires 26 Mar 2030
United StatesGUDID listing GUDID NumberE312362040061 UDI-DI Date3 Feb 2022ListedStatusListed GUDID: in commercial distribution

Certificates

1 certificate · EUDAMED

EUDAMED certificates (1)
  • 1000183128 Active

    Quality management system EU MDR

    Certifier
    DQS Medizinprodukte GmbH 0297
    Issued
    27 Mar 2025
    Expires
    26 Mar 2030

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  • Withdrawn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
Stahlbohrer EUDAMED
Edenta GUDID
Generic Name
Steel dental bur, reusable
Device Name
HM-/Stahl-Bohrer
Model / Reference
10521, 36.204.006
Primary DI / UDI-DI
E312362040061
Basic UDI-DI
++E31210521CQ
Unit of Use DI
E31236204006101
FDA Product Code
EJL
EMDN Code
L159007 Odontostomatology burs, reusable
GMDN Term
Steel dental bur, reusable
Device Class
Class IIa EUDAMED
Class I GUDID
Regulation Number
872.3240
EU market of registration
Liechtenstein
GUDID distribution status
In Commercial Distribution
Sterilization Method
Moist Heat or Steam Sterilization

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device ClassEUDAMED
Class IIa
GUDID
Class I

Manufacturer details

EUDAMED SRN
LI-MF-000011937

Other devices from Edenta Etablissement

See all devices from Edenta Etablissement →

Properties

  • Premarket Exempt
  • Lot / Batch Number
  • Manufacturing Date

Other properties (21)

  • Sterile: No
  • Single Use: 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
  • Prescription Use: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Serial Number: No
  • Expiration Date: No