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BC Sealer ION+

by Angelus Indústria De Produtos Odontológicos S/a 2 variants

Ref 08.650.00.016.XXModel Bioceramics

Active European Union

CE MDR

Valid until

Not listed

EUDAMED holds no validity date

FDA recalls

Not applicable

No FDA record for this device

Documents

None linked in EUDAMED

A group certificate may exist

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, synced 24 Oct 2026. What this means

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number807865BIOCERAMICSQN Basic UDI-DI 07901017702662UDI-DIDate17 Dec 2025RegisteredStatusActive

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

1 jurisdiction

SwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

European Union — CE/MDR Active

Specification

EUDAMED

Model / Reference
Bioceramics, 08.650.00.016.XX
Primary DI / UDI-DI
07901017702662
Basic UDI-DI
807865BIOCERAMICSQN
EMDN Code
Q01010202 Root canal filling dental cements
Device Class
Class IIa
EU market of registration
Germany

Manufacturer details

EUDAMED SRN
BR-MF-000010255
Authorised representative
Emergo Europe B.V. NL-AR-000000116

Other devices from Angelus Indústria De Produtos Odontológicos S/a

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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