Skip to content

protoCORE Dual-cured core build-up composite

by Meta Biomed Co., Ltd. 13 variants

Model NexCore Dual syringe Blue

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 25 Oct 2026. What this means

Regulatory status

as of registry sync 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD NumberB-08806387861034 Basic UDI-DI 08806387861034UDI-DIDate12 Jun 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  • Withdrawn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
Dual-Cured Core Build-up Composite Resin
Model / Reference
NexCore Dual syringe Blue
Primary DI / UDI-DI
08806387861034
Basic UDI-DI
B-08806387861034
EMDN Code
Q01010103 Dental restorative composites
Device Class
Class IIa
EU market of registration
Germany

Manufacturer details

EUDAMED SRN
KR-MF-000009681
Authorised representative
Meta Biomed Europe GmbH DE-AR-000004953

Other devices from Meta Biomed Co., Ltd.

See all devices from Meta Biomed Co., Ltd. →

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