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ARGELITE 49 (10g)

by The Argen Corporation EUDAMED

Active European Union

Ref 104561

Regulatory status

as of 27 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number++D818DENTALALLOYS01PE9 Basic UDI-DIDate28 Aug 2026RegisteredStatusActive

Coverage

1 jurisdiction

SwedenSwedenSwedenSwedenLatviaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainGreeceCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not known
  • Not covered

European Union — CE/MDR Active

EU market availability

Available in 20 countries, as listed in EUDAMED:

  • Austria
  • Belgium
  • Bulgaria
  • Cyprus
  • Denmark
  • France
  • Germany
  • Greece
  • Hungary
  • Ireland
  • Italy
  • Latvia
  • Lithuania
  • Netherlands
  • Poland
  • Portugal
  • Romania
  • Slovenia
  • Spain
  • Sweden

Last checked 27 Oct 2026.

Certificates: none listed in EUDAMED

Specification

EUDAMED

Device Name
ARGELITE 49 (10g)
Model / Reference
104561
Primary DI / UDI-DI
+D81810456102
Basic UDI-DI
++D818DENTALALLOYS01PE9
EMDN Code
Q010601 Dental alloys
Device Class
Class IIa
Market of Registration
Germany

Manufacturer details

EUDAMED SRN
US-MF-000022069
Authorised representative
MDSS GmbH DE-AR-000005430

Other devices from The Argen Corporation

See all devices from The Argen Corporation →

Properties

  • Implantable

Other properties (12)

  • Sterile: 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