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Magnum Splendidum

by Mesa Italia S.r.l. 23 variants

Ref 41010362AModel Alloys for full-cast metal crowns and FPDs - Alloys for metal-ceramic crowns and FPDs

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

CE MDR

Valid until

31 Jan 2028

CE MDR certificate

FDA recalls

Not checked

No FDA submission to match recalls against

Documents

1 certificate

Certifier ICIM S.P.A.

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, GUDID, synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number80506122000000000000001TW Basic UDI-DI 08050612200147UDI-DIDate12 Jun 2023RegisteredStatusActive
United StatesGUDID listing GUDID Number08050612200147 UDI-DI Date22 Jun 2016ListedStatusListed GUDID: in commercial distribution

Certificates

1 certificate · EUDAMED

EUDAMED certificates (1)
  • 0425-MDR-030016-00 Active

    Quality management system EU MDR

    Certifier
    ICIM S.P.A. 0425
    Issued
    1 Feb 2023
    Expires
    31 Jan 2028

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  • Withdrawn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

Generic Name
Dental casting non-noble alloy
Model / Reference
Alloys for full-cast metal crowns and FPDs - Alloys for metal-ceramic crowns and FPDs EUDAMED
41010362A EUDAMED
1 GUDID
Primary DI / UDI-DI
08050612200147
Basic UDI-DI
80506122000000000000001TW
Direct Marketing DI
08050612200147
FDA Product Code
EJH
EMDN Code
Q010601 Dental alloys
GMDN Term
Dental casting non-noble alloy
Device Class
Class IIa EUDAMED
Class II GUDID
Regulation Number
872.3710
EU market of registration
Italy
GUDID distribution status
In Commercial Distribution
MRI Safety
MR Conditional

Truth per registry

2 sources · 2 fields differ

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

Manufacturer details

EUDAMED SRN
IT-MF-000029407

Related devices

Category: Dental casting non-noble alloy

Other devices from Mesa Italia S.r.l.

See all devices from Mesa Italia S.r.l. →

Properties

  • Implantable YesEUDAMEDNoGUDID
  • Premarket Exempt
  • Lot / Batch Number
  • Expiration Date

Other properties (20)

  • 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
  • Prescription Use: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Serial Number: No
  • Manufacturing Date: No