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Profiller

by Himg Serami̇k Ve Medi̇kal Kompozi̇t Sanayi̇ Ti̇caret Li̇mi̇ted Şi̇rketi̇ 14 variants

Ref RKM01A1Model Universal Restorative Composite A1

Active European Union

CE MDD

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/MDD NumberB-08680812015496 Basic UDI-DI 08680812015496UDI-DIDate21 Sep 2026RegisteredStatusActive

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  • Withdrawn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/MDD Active

Specification

EUDAMED

Device Name
Dental Filling Material
Model / Reference
Universal Restorative Composite A1, RKM01A1
Primary DI / UDI-DI
08680812015496
Basic UDI-DI
B-08680812015496
EMDN Code
Q01010103 Dental restorative composites
Device Class
Class IIa
EU market of registration
Türkiye

Manufacturer details

EUDAMED SRN
TR-MF-000025302

Other devices from Himg Serami̇k Ve Medi̇kal Kompozi̇t Sanayi̇ Ti̇caret Li̇mi̇ted Şi̇rketi̇

See all devices from Himg Serami̇k Ve Medi̇kal Kompozi̇t Sanayi̇ Ti̇caret Li̇mi̇ted Şi̇rketi̇ →

Properties

  • Implantable

Other properties (10)

  • Sterile: No
  • Reusable: No
  • Contains Latex: No
  • Reprocessed: No
  • Human-derived: No
  • Human Tissues: No
  • Animal Tissues: No
  • Administering Medicine: No
  • Measuring Function: No
  • Incorporates Medicinal Product: No