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SPEC 3 LED Australia Plug Type IA

by Coltene/Whaledent Inc. EUDAMEDGUDID

Active European Union EUDAMED: not on the EU market

Ref 60013944

Regulatory status

as of 29 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number++D661076L2 Basic UDI-DIDate31 Mar 2026RegisteredStatusActive
United StatesGUDID listing GUDID NumberD661600139440 UDI-DIDate16 Aug 2016ListedStatusListed GUDID: in commercial distribution

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  • Withdrawn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 22 Oct 2026.

Specification

EUDAMED · GUDID

Trade Name
SPEC 3 LED Australia Plug Type IA EUDAMED
Spec 3 GUDID
Generic Name
Dental/surgical polymerization lamp
Device Name
LED Curing Lights
Model / Reference
60013944
Primary DI / UDI-DI
D661600139440
Basic UDI-DI
++D661076L2
FDA Product Code
EBZ
EMDN Code
Q01010199 Dental restoration devices - other
GMDN Term
Dental/surgical polymerization lamp
Device Class
Class I EUDAMED
Class II GUDID
Regulation Number
872.6070
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device ClassEUDAMED
Class I
GUDID
Class II

Manufacturer details

EUDAMED SRN
US-MF-000015761
Authorised representative
Coltène/Whaledent GmbH + Co. KG DE-AR-000005719

Related devices

Category: Dental appliance fabrication material, ceramic

Other devices from Coltene/Whaledent Inc.

See all devices from Coltene/Whaledent Inc. →

Properties

  • Serial Number

Other properties (23)

  • 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
  • Lot / Batch Number: No
  • Expiration Date: No
  • Manufacturing Date: No