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Bluephase G4 100-240V blue & Radiometer

by Ivoclar Vivadent AG

Ref 691253BU

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

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 Number76152081XLAMP001YD Basic UDI-DI 07615208458558UDI-DIDate25 Nov 2025RegisteredStatusActive
United StatesGUDID listing GUDID Number07615208458558 UDI-DI Date21 Nov 2022ListedStatusListed GUDID: 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  • Withdrawn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
Bluephase G4 100-240V blue & Radiometer EUDAMED
Bluephase G4 GUDID
Generic Name
Dental/surgical polymerization lamp
Device Name
Bluephase EasyCure, Bluephase G4 100, Bluephase G4, Bluephase N G4, Bluephase N-Cure, Bluephase PowerCure
Model / Ref / Catalog
691253BU
Primary DI / UDI-DI
07615208458558
Basic UDI-DI
76152081XLAMP001YD
Direct Marketing DI
07615208461343
FDA Product Code
EBZ
EMDN Code
Z12119003 Cold light dental equipment
GMDN Term
Dental/surgical polymerization lamp
Device Class
Class I EUDAMED
Class II GUDID
Regulation Number
872.6070
EU market of registration
Liechtenstein
GUDID distribution status
In Commercial Distribution
Sterilization Method
Moist Heat or Steam Sterilization

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device ClassEUDAMED
Class I
GUDID
Class II

Manufacturer details

EUDAMED SRN
LI-MF-000000522

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See all devices from Ivoclar Vivadent AG →

Properties

  • Prescription Use
  • Serial Number
  • Manufacturing Date

Other properties (21)

  • 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
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No
  • Lot / Batch Number: No
  • Expiration Date: No