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Reamer mit Handgriff

by Edenta Etablissement 56 variants

Part of a family of 263 devices: see the family page

Ref 171.25.654.050Model 16411

Reamer mit Handgriff (171.25.654.050) is a device classified as Class IIa in the EU and Class I in the US made by Edenta Etablissement, registered in EUDAMED on 2 Feb 2022 (Basic UDI-DI ++E31216411DS) with CE/MDR certificate 1000183128 valid until 26 Mar 2030 and listed in FDA GUDID since 3 Feb 2022 (UDI-DI E312171256540501), active as of 22 Oct 2026.

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

Source EUDAMED, GUDID, synced 22 Oct 2026.

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 NumberE312171256540501 UDI-DI Date3 Feb 2022ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI ++E31216411DS registered 2 Feb 2022 Active· +1 more in the status table
  • FDA GUDID UDI-DI E312171256540501 listed 3 Feb 2022 Listed

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

Timeline

4 dated events

  1. Registered EUDAMED ++E31216411DS
  2. Listed FDA GUDID E312171256540501
  3. Certificate issued EUDAMED 1000183128
  4. Certificate expires EUDAMED 1000183128

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  • Withdrawn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
Reamer mit Handgriff EUDAMED
Edenta GUDID
Generic name
Manual endodontic file/rasp, reusable
Device name
Endo-Instrumente
Model / reference
16411, 171.25.654.050
Primary DI / UDI-DI
E312171256540501
Basic UDI-DI
++E31216411DS
Unit of use DI
E31217125654050101
FDA product code
DZA
EMDN code
L159004 Endodontic rasps and files, reusable
GMDN term
Manual endodontic file/rasp, reusable
Device class
Class IIa EUDAMED
Class I GUDID
Regulation number
872.4130
EU registration type
Standard device
EU market of registration
Liechtenstein
GUDID distribution status
In Commercial Distribution
Sterilisation method
Moist Heat or Steam Sterilization

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.

Manufacturer details

EUDAMED SRN
LI-MF-000011937

Related devices

Category: Manual endodontic file/rasp, reusable

Similar devices in this category

Other devices filed under ODONTOSTOMATOLOGY INSTRUMENTS, REUSABLE - VARIOUS.

Other devices from Edenta Etablissement

See all devices from Edenta Etablissement →

Properties

  • Sterilise before use
  • Premarket exempt
  • Lot / batch number
  • Manufacturing date
Other properties (21, all answered No)