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Coated implant drills and accessories

by Carmex Precision Tools Ltd. EUDAMEDGUDID

Active European Union

Ref SD2024L16C

Regulatory status

as of 29 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number729011953DDC023H Basic UDI-DIDate20 Oct 2025RegisteredStatusActive
United StatesGUDID listing GUDID Number07290119530717 UDI-DIDate30 Sep 2025ListedStatusListed GUDID: in commercial distribution

Coverage

2 jurisdictions

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  • Withdrawn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

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.

Recalls

0 recalls · FDA

No FDA recalls on record, checked 22 Oct 2026.

Specification

EUDAMED · GUDID

Trade Name
Twist drill
Generic Name
Fixture/appliance dental drill bit, reusable
Device Name
Coated implant drills and accessories
Model / Reference
SD2024L16C
Primary DI / UDI-DI
07290119530717
Basic UDI-DI
729011953DDC023H
FDA Product Code
NDP
EMDN Code
Z12110102 Dental drills
GMDN Term
Fixture/appliance dental drill bit, reusable
Device Class
Class IIa EUDAMED
Class I GUDID
Regulation Number
872.3980
Market of Registration
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
IL-MF-000014627
Authorised representative
MedNet EC-REP GmbH DE-AR-000000002

Other devices from Carmex Precision Tools Ltd.

See all devices from Carmex Precision Tools Ltd. →

Properties

  • Reusable
  • Premarket Exempt

Other properties (22)

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