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H-FILES (Nickel-Titanium) 25m/m 60

by DiaDent Group International

Ref H-FILES 25mm #60 / NT503-212

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

CE MDR

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 23 Oct 2026. What this means

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number88063835EIF3J Basic UDI-DI 08806383532983UDI-DIDate6 May 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number08806383532983 UDI-DI Date11 Jun 2020ListedStatusListed 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  • Withdrawn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 Active
  • United States GUDID listing Listed

Specification

EUDAMED · GUDID

Trade Name
Endodontic Ni-Ti Hand Files EUDAMED
H-FILES (Nickel-Titanium) GUDID
Generic Name
Manual endodontic file/rasp, reusable
Device Name
Endodontic Instruments
Model / Ref / Catalog
H-FILES 25mm #60 / NT503-212 EUDAMED
25m/m 60 GUDID
NT503-212 GUDID
Primary DI / UDI-DI
08806383532983
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 market of registration
Netherlands
GUDID distribution status
In Commercial Distribution
Sterilization Method
Moist Heat or Steam Sterilization

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Model / ReferenceEUDAMED
H-FILES 25mm #60 / NT503-212
GUDID
25m/m 60

Related devices

Category: Manual endodontic file/rasp, reusable

Other devices from DiaDent Group International

See all devices from DiaDent Group International →

Properties

  • Reusable
  • Prescription Use
  • Premarket Exempt

Other properties (21)

  • 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
  • Lot / Batch Number: No
  • Serial Number: No
  • Expiration Date: No
  • Manufacturing Date: No