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Exact Lightbody medium Fast

by DETAX GmbH & Co. KG

Ref 02978

Withdrawn Withdrawn in European Union.

Was authorized under CE MDR, withdrawn

Ended

Withdrawn

Date not published (CE MDR)

FDA recalls

Not applicable

No FDA record for this device

Documents

None linked in EUDAMED

A group certificate may exist

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, synced 24 Oct 2026. What this means

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number++EDET00158 Basic UDI-DI +EDET029781UDI-DIDate18 Nov 2021RegisteredStatusWithdrawn

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

1 jurisdiction

SwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

European Union — CE/MDR Withdrawn

Specification

EUDAMED

Device Name
Dental-Abdruckmaterial, Silikongummi
Model / Reference
02978
Primary DI / UDI-DI
+EDET029781
Basic UDI-DI
++EDET00158
EMDN Code
Q01020104 Dental impression silicones
Device Class
Class IIa
EU market of registration
Sweden

Manufacturer details

EUDAMED SRN
DE-MF-000005995

Related devices

Category: Silicone dental impression material

Other devices from DETAX GmbH & Co. KG

See all devices from DETAX GmbH & Co. KG →

Properties

Other properties (13)

  • 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