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Neo Spectra ST HV Refill A3.5

by Dentsply DeTrey GmbH

Ref 60701975

Active European Union

CE MDR

Valid until

Not listed

EUDAMED holds no validity date

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 25 Oct 2026. What this means

Regulatory status

as of registry sync 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number++D010FIM03R3 Basic UDI-DI D010607019751UDI-DIDate23 Sep 2026RegisteredStatusActive

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  • Withdrawn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 Active

Specification

EUDAMED

Device Name
Ceram.x Spectra ST, TPH Spectra ST, Neo Spectra ST
Model / Reference
60701975
Primary DI / UDI-DI
D010607019751
Basic UDI-DI
++D010FIM03R3
Unit of Use DI
D010607019750
EMDN Code
Q01010103 Dental restorative composites
Device Class
Class IIa
EU market of registration
Poland

Manufacturer details

EUDAMED SRN
DE-MF-000005905

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See all devices from Dentsply DeTrey GmbH →

Properties

  • Implantable
  • CMR Substance

Other properties (11)

  • Sterile: No
  • Reusable: No
  • Contains Latex: No
  • Reprocessed: No
  • Human-derived: No
  • Human Tissues: No
  • Animal Tissues: No
  • Endocrine Disruptor: No
  • Administering Medicine: No
  • Measuring Function: No
  • Incorporates Medicinal Product: No