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Twist Step Drill 2.3/2.8mmD x 8-18mmL

by Medigma Biomedical GmbH

Ref 1828DM, DL1828Model Twist Step Drill

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

CE MDR CE MDD

Valid until

Not listed

EUDAMED holds no validity date

FDA recalls

Not checked

No FDA submission to match recalls against

Documents

None linked in EUDAMED

A group certificate may exist

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 NumberB-DEMF0000094121828DM3D Basic UDI-DI Date16 Jun 2022RegisteredStatusActive
European UnionCE/MDD EUDAMED NumberB-DEMF0000094121828DM3D Basic UDI-DI Date16 Jun 2022RegisteredStatusActive
United StatesGUDID listing GUDID NumberD-DEMF0000094121828DM3D UDI-DI Date23 Apr 2017ListedStatusListed GUDID: in commercial distribution

Certificates

0 certificates · EUDAMED

EUDAMED lists no certificate for this device's Basic UDI-DI.

A certificate issued for a device group may exist without being linked here.

Coverage

2 jurisdictions

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  • Withdrawn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

Specification

EUDAMED · GUDID

Generic Name
Fluted surgical drill bit, reusable
Device Name
Twist Step Drill
Model / Reference
Twist Step Drill, 1828DM, DL1828
Primary DI / UDI-DI
D-DEMF0000094121828DM3D, 04260525160931, 07290105150158
Basic UDI-DI
B-DEMF0000094121828DM3D, 426052516TwistStepDrill8Z, 729010515TwistStepDrill9Y
FDA Product Code
EJL
EMDN Code
Z12110102 Dental drills
GMDN Term
Fluted surgical drill bit, reusable
Device Class
Class IIa EUDAMED
Class I GUDID
Regulation Number
872.3240
EU market of registration
Türkiye
Germany
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
DE-MF-000009412

Other devices from Medigma Biomedical GmbH

See all devices from Medigma Biomedical GmbH →

Properties

  • Reusable YesEUDAMEDNoEUDAMED
  • Prescription Use
  • Premarket Exempt
  • Lot / Batch Number
  • Manufacturing Date

Other properties (19)

  • Sterile: No
  • Single Use: No
  • Implantable: 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