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File Measure Set

by Diadent Group International

Ref 780-001Model FILE MEASURE SET

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, self-declared

Class I: no certifier involved

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, GUDID, synced 25 Oct 2026. What this means

Regulatory status

as of registry sync 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number88063835EIH3N Basic UDI-DI 08806383522946UDI-DIDate6 May 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number08806383522946 UDI-DI Date18 Aug 2020ListedStatusListed GUDID: in commercial distribution

Certificates

0 certificates · EUDAMED

No certifier certificate is listed. Devices of this class are self-declared by the manufacturer.

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  • Withdrawn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

Generic Name
Endodontic instrument chairside holder set
Model / Ref / Catalog
FILE MEASURE SET, 780-001
Primary DI / UDI-DI
08806383522946
Basic UDI-DI
88063835EIH3N
FDA Product Code
EIL
EMDN Code
Q010199 Conservative dentistry and endodontics devices - other
GMDN Term
Endodontic instrument chairside holder set
Device Class
Class I
Regulation Number
872.4565
EU market of registration
Netherlands
GUDID distribution status
In Commercial Distribution

Manufacturer details

EUDAMED SRN
KR-MF-000023806
Authorised representative
Diadent Europe B.V. NL-AR-000012597

Other devices from Diadent Group International

See all devices from Diadent Group International →

Properties

  • Single Use
  • Prescription Use
  • Premarket Exempt

Other properties (21)

  • Sterile: No
  • Implantable: No
  • Reusable: 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