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REAMERS 25m/m ASST 45/80

by DiaDent Group International

Ref REAMERS 25mm #45/80 / SS501-292

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

CE MDR

Valid until

No date given

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 23 Oct 2026. What this means

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number88063835EIF3J Basic UDI-DI 08806383538152UDI-DIDate6 May 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number08806383538152 UDI-DI Date11 Jun 2020ListedStatusListed GUDID: in commercial distribution

Official records

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  • Withdrawn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 Active
  • United States GUDID listing Listed

Specification

EUDAMED · GUDID

Trade name
Endodontic Stainless Steel Hand Files EUDAMED
Reamers GUDID
Generic name
Manual endodontic file/rasp, reusable
Device name
Endodontic Instruments
Model / Ref / Catalog
REAMERS 25mm #45/80 / SS501-292 EUDAMED
25m/m ASST 45/80 GUDID
SS501-292 GUDID
Primary DI / UDI-DI
08806383538152
Basic UDI-DI
88063835EIF3J
FDA product code
EKS
EMDN code
L159004 Endodontic rasps and files, reusable
GMDN term
Manual endodontic file/rasp, reusable
Device class
Class I
Regulation number
872.4565
EU registration type
Standard device
EU market of registration
Netherlands
GUDID distribution status
In Commercial Distribution
Sterilisation method
Moist Heat or Steam Sterilization

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Model / referenceEUDAMED
REAMERS 25mm #45/80 / SS501-292
GUDID
25m/m ASST 45/80

Related devices

Category: Manual endodontic file/rasp, reusable

Other devices from DiaDent Group International

See all devices from DiaDent Group International →

Properties

  • Sterilise before use
  • Reusable
  • Prescription use
  • Premarket exempt

Other properties (21)

  • Supplied sterile: No
  • Single use: No
  • Implantable: No
  • Contains latex: No
  • Reprocessed single-use device: No
  • Contains CMR substances (carcinogenic, mutagenic or toxic to reproduction): No
  • Incorporates a substance derived from human blood or plasma: No
  • Contains human tissues or cells: No
  • Contains animal tissues or cells: No
  • Contains endocrine-disrupting substances: No
  • Administering medicine: No
  • Measuring function: No
  • Incorporates a medicinal substance: 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