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Regofix transparent 1

by Dreve Dentamid GmbH 2 variants

Ref D504876

Active European Union. Also listed in GUDID (US), not in commercial distribution.

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 24 Oct 2026. What this means

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number++E2390017Y7 Basic UDI-DI +E239D5048761UDI-DIDate18 May 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number+E239D5048761 UDI-DI Date7 Oct 2016ListedStatusListed GUDID: not 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  • Withdrawn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
Regofix transparent
Generic Name
Silicone dental impression material
Device Name
Bissregistriermaterial auf Vinylpolysiloxanbasis
Model / Ref / Catalog
D504876, 1
Primary DI / UDI-DI
+E239D5048761 EUDAMED
E239D5048761 GUDID
Basic UDI-DI
++E2390017Y7
FDA Product Code
ELW
EMDN Code
Q01020102 Dental impression vinylsiloxans
GMDN Term
Silicone dental impression material
Device Class
Class IIa EUDAMED
Class II GUDID
Regulation Number
872.3660
EU market of registration
Germany
GUDID distribution status
Not in Commercial Distribution

Truth per registry

2 sources · 3 fields differ

FieldEUDAMEDGUDID
Model / ReferenceEUDAMED
D504876
GUDID
1
Primary DI / UDI-DIEUDAMED
+E239D5048761
GUDID
E239D5048761
Device ClassEUDAMED
Class IIa
GUDID
Class II

Other devices from Dreve Dentamid GmbH

See all devices from Dreve Dentamid GmbH →

Properties

  • Lot / Batch Number
  • Expiration Date

Other properties (22)

  • 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
  • Prescription Use: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No
  • Serial Number: No
  • Manufacturing Date: No