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Multilink Automix / Primer A+B 615218US

by Ivoclar Vivadent Aktiengesellschaft EUDAMEDGUDID

Active European Union

Ref 615218US

Regulatory status

as of 28 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing GUDID Number07615208594423 UDI-DIDate3 Sep 2026ListedStatusListed GUDID: in commercial distribution
European UnionCE/MDR EUDAMED Number76152082ACEME001DV Basic UDI-DIDate20 May 2026RegisteredStatusActive

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  • Withdrawn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 24 Oct 2026.

Specification

EUDAMED · GUDID

Trade Name
Multilink Automix Refill Opaque Easy EUDAMED
Multilink Automix / Primer A+B GUDID
Generic Name
Dentine bonding agent/set
Device Name
Multilink Automix / Primer A+B, Multilink N, Variolink Esthetic, Variolink 100, Variolink N, Variolink N-Esthetic DC
Model / Ref / Catalog
615218US
Primary DI / UDI-DI
07615208594423
Basic UDI-DI
76152082ACEME001DV
FDA Product Code
EBF
EMDN Code
Q0101010201 Dental base cements
GMDN Term
Dentine bonding agent/set
Device Class
Class IIa EUDAMED
Class II GUDID
Regulation Number
872.3690
Market of Registration
Liechtenstein
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Device ClassEUDAMED
Class IIa
GUDID
Class II
ImplantableEUDAMED
Yes
GUDID
No

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Properties

  • Implantable YesEUDAMEDNoGUDID
  • Prescription Use
  • Lot / Batch Number
  • Expiration Date
  • Manufacturing Date

Other properties (19)

  • Sterile: No
  • Single Use: 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
  • Serial Number: No