Skip to content

Drufosoft® D42483X18

by Dreve Dentamid GmbH

Ref D42483X18

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 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number++E2390026Y8 Basic UDI-DI +E239D42483X181UDI-DIDate18 May 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number+E239D42483X181 UDI-DI Date19 Aug 2022ListedStatusListed 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  • Withdrawn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
Drufosoft®
Generic Name
Dental appliance fabrication material, thermoplastic
Device Name
Dentales Schienungsmaterial langzeit
Model / Ref / Catalog
D42483X18
Primary DI / UDI-DI
+E239D42483X181 EUDAMED
E239D42483X181 GUDID
Basic UDI-DI
++E2390026Y8
FDA Product Code
KMY
EMDN Code
Q010699 Materials for the preparation of custom-made dental devices - other
GMDN Term
Dental appliance fabrication material, thermoplastic
Device Class
Class IIa EUDAMED
Class I GUDID
Regulation Number
872.5525
EU market of registration
Germany
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Primary DI / UDI-DIEUDAMED
+E239D42483X181
GUDID
E239D42483X181
Device ClassEUDAMED
Class IIa
GUDID
Class I

Related devices

Category: Dental appliance fabrication material, thermoplastic

Other devices from Dreve Dentamid GmbH

See all devices from Dreve Dentamid GmbH →

Properties

  • Prescription Use
  • Premarket Exempt
  • Lot / Batch Number
  • Expiration Date

Other properties (20)

  • Sterile: No
  • Single Use: 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
  • Serial Number: No
  • Manufacturing Date: No