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DIATECH Z-REX Diamonds

by Dent4You AG EUDAMEDGUDID

Active European Union

Ref 60032482Model DIATECH Diamond Instruments

Regulatory status

as of 29 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing GUDID Number07630243665693 UDI-DIDate1 Sep 2026ListedStatusListed GUDID: in commercial distribution
European UnionCE/MDR EUDAMED Number76303929ROTA20011CP Basic UDI-DIDate11 Jun 2026RegisteredStatusActive

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  • Withdrawn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 23 Oct 2026.

Specification

EUDAMED · GUDID

Trade Name
DIATECH Z-REX Diamonds EUDAMED
DIATECH Diamonds GUDID
Generic Name
Dental material mixing nozzle
Model / Ref / Catalog
DIATECH Diamond Instruments, 60032482
Primary DI / UDI-DI
07630243665693
Basic UDI-DI
76303929ROTA20011CP
FDA Product Code
EID
EMDN Code
Q010199 Conservative dentistry and endodontics devices - other
GMDN Term
Dental material mixing nozzle
Device Class
Class IIa EUDAMED
Class I GUDID
Regulation Number
872.4565
Market of Registration
Germany
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device ClassEUDAMED
Class IIa
GUDID
Class I

Manufacturer details

EUDAMED SRN
CH-MF-000028926
Authorised representative
Coltène/Whaledent GmbH + Co. KG DE-AR-000005719

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Properties

  • Single Use
  • Reusable
  • Prescription Use
  • Premarket Exempt
  • Lot / Batch Number
  • Manufacturing Date

Other properties (18)

  • Sterile: 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
  • Serial Number: No
  • Expiration Date: No