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Astringedent X

by Ultradent Products, Inc. United States EUDAMED

Ref 112

EMDN M040504

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number0883205-TF020AH Basic UDI-DIDate29 May 2026RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Not covered

European Union — CE/MDR Active

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 24 Oct 2026

Device Name
Ferric Sulfate Hemostatic Solutions
Model / Reference
112
Primary DI / UDI-DI
00883205042446
Basic UDI-DI
0883205-TF020AH, 0883205-TF020AstringXDL
EMDN Code
M040504 Inorganic haemostatic devices
Device Class
Class IIa
Market of Registration
Germany

Manufacturer details

EUDAMED SRN
US-MF-000013697
Authorised representative
Ultradent Products GmbH DE-AR-000006666

Other devices from Ultradent Products, Inc.

See all devices from Ultradent Products, Inc. →

Properties & raw data

Show properties, registry sources and raw records
Other properties (13)
  • Sterile: 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

Sources (2)

  • EUDAMED 123355cb-dca0-4042-b5dc-452b702a4596 61 fields · synced 24 Oct 2026
  • EUDAMED 00883205042446|0883205-TF020ASTRINGXDL 61 fields · synced 24 Oct 2026