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CHARISMA Bulk Flow ONE

by KULZER GmbH

Ref 000000000066094725

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 23 Oct 2026. What this means

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number++J0141103COMP010103i8C Basic UDI-DI +J014660947250UDI-DIDate3 Aug 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  • Withdrawn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/MDR Active

Specification

EUDAMED

Device Name
Dental Flowable Composite Resin
Model / Reference
000000000066094725
Primary DI / UDI-DI
+J014660947250
Basic UDI-DI
++J0141103COMP010103i8C
EMDN Code
Q01010103 Dental restorative composites
Device Class
Class IIa
Market of Registration
Poland

Manufacturer details

EUDAMED SRN
DE-MF-000007705

Other devices from Kulzer, Inc.

See all devices from Kulzer, Inc. →

Properties

  • Implantable
  • CMR Substance

Other properties (11)

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