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VioSeal

by Spident

Ref #450400

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

CE MDR CE MDD

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 23 Oct 2026. What this means

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED NumberB-08809262954371 Basic UDI-DI 08809262954371UDI-DIDate7 May 2026RegisteredStatusActive
European UnionCE/MDD EUDAMED NumberB-08809262954371 Basic UDI-DI 08809262954371UDI-DIDate7 May 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number08809262954371 UDI-DI Date20 Apr 2026ListedStatusListed 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  • Withdrawn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, CE/MDD Active
  • United States GUDID listing Listed

Specification

EUDAMED · GUDID

Generic Name
Hygroscopic dental cement
Model / Ref / Catalog
#450400, VioSeal
Primary DI / UDI-DI
08809262954371
Basic UDI-DI
B-08809262954371, 880926295VS47
Direct Marketing DI
08809262954371
FDA Product Code
KIF
EMDN Code
Q01010201 Root canal filling dental pastes
GMDN Term
Hygroscopic dental cement
Device Class
Class IIa EUDAMED
Class II GUDID
Regulation Number
872.3820
EU market of registration
Bulgaria
Greece
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Model / ReferenceEUDAMED
#450400
GUDID
VioSeal
Device ClassEUDAMED
Class IIa
GUDID
Class II

Manufacturer details

EUDAMED SRN
KR-MF-000008691
Authorised representative
AR Experts B.V. NL-AR-000023989

Other devices from Spident

See all devices from Spident →

Properties

  • Implantable
  • Lot / Batch Number
  • Expiration Date
  • Manufacturing 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
  • Premarket Exempt: No
  • Serial Number: No