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EasyTip 320 Pack 25 6498062

by SIRONA Dental Systems GmbH

Ref 6498062

EasyTip 320 Pack 25 6498062 is a device classified as Class IIa in the EU and Class II in the US made by SIRONA Dental Systems GmbH, registered in EUDAMED on 19 Oct 2026 (Basic UDI-DI ++E276sterilLaserTipV012U) and listed in FDA GUDID since 26 Mar 2020 (UDI-DI +E27664980622), active as of 7 Nov 2026.

Active European Union. Also listed in GUDID (US).

CE MDR

Valid until

No date given

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

Source EUDAMED, GUDID, synced 7 Nov 2026.

Regulatory status

as of registry sync 7 Nov 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number++E276sterilLaserTipV012U Basic UDI-DI +E27664980622UDI-DIDate19 Oct 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number+E27664980622 UDI-DI Date26 Mar 2020ListedStatusListed GUDID: in commercial distribution

Official records

  • EUDAMED public site Basic UDI-DI ++E276sterilLaserTipV012U — open Devices and search for it

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI ++E276sterilLaserTipV012U registered 19 Oct 2026 Active
  • FDA GUDID UDI-DI +E27664980622 listed 26 Mar 2020 Listed

Timeline

2 dated events

  1. Listed FDA GUDID +E27664980622
  2. Registered EUDAMED ++E276sterilLaserTipV012U

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  • Withdrawn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
EasyTip 320 Pack 25
Generic name
Dental diode laser system
Device name
EasyTip
Model / reference
6498062
Primary DI / UDI-DI
+E27664980622 EUDAMED
E27664980622 GUDID
Basic UDI-DI
++E276sterilLaserTipV012U
FDA product code
GEX
EMDN code
Z12011085 Laser surgery instruments - consumables
GMDN term
Dental diode laser system
Device class
Class IIa EUDAMED
Class II GUDID
Regulation number
878.4810
EU registration type
Standard device
EU market of registration
Germany
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 3 fields differ

FieldEUDAMEDGUDID
Primary DI / UDI-DIEUDAMED
+E27664980622
GUDID
E27664980622
Device classEUDAMED
Class IIa
GUDID
Class II
Supplied sterileEUDAMED
No
GUDID
Yes

The registries describe this device under different primary UDI-DIs (EUDAMED lists +E27664980622; FDA GUDID lists E27664980622), so their flags are not compared. Device class is stated on each registry's own scale: Class IIa in the EU (EUDAMED), Class II in the US (FDA GUDID). EU and US classes are different schemes, so this is not a disagreement.

Related devices

Category: Dental diode laser system

Similar devices in this category

Other devices filed under LASER SURGERY INSTRUMENTS - CONSUMABLES.

Other devices from SIRONA Dental Systems GmbH

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Properties

  • Supplied sterile NoEUDAMEDYesGUDID
  • Single use
  • Prescription use
  • Lot / batch number
  • Expiration date
  • Manufacturing date
Other properties (19, all answered No)