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BISICO Regidur I 10x50ml

by Bisico Bielefelder Dentalsilicone GmbH & Co. KG EUDAMED

Active European Union

Ref 71575

Regulatory status

as of 28 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR NumberB-+EBIB715751 Basic UDI-DIDate24 Aug 2026RegisteredStatusActive
European UnionCE/MDD NumberB-+EBIB715751 Basic UDI-DIDate24 Aug 2026RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not known
  • Not covered

European Union — CE/MDR, CE/MDD Active

Certificates

0 certificates · EUDAMED

No notified-body certificate is listed. Devices of this class are self-declared by the manufacturer.

Specification

EUDAMED

Device Name
BISICO Addition-curing dental impression silicone
Model / Reference
71575
Primary DI / UDI-DI
+EBIB715751
Basic UDI-DI
B-+EBIB715751, ++EBIB019SILI7U
EMDN Code
Q01020104 Dental impression silicones
Device Class
Class I
Class IIa
Market of Registration
Germany

Manufacturer details

EUDAMED SRN
DE-MF-000011554

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Properties

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