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Hi-Bond Universal

by MEDICLUS Co., Ltd.

Ref Hi-Bond UniversalModel 303-2 Hi-Bond Universal, 303-3 Hi-Bond Universal 2.5

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 Number880951834RS06NP Basic UDI-DI 08809518343409UDI-DIDate20 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  • Withdrawn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 adhesive material
Model / Reference
303-2 Hi-Bond Universal, 303-3 Hi-Bond Universal 2.5, Hi-Bond Universal
Primary DI / UDI-DI
08809518343409
Basic UDI-DI
880951834RS06NP
Direct Marketing DI
08809518343409
EMDN Code
Q01010104 Dental bonding agents
Device Class
Class IIa
EU market of registration
Romania

Manufacturer details

EUDAMED SRN
KR-MF-000022584
Authorised representative
KTR Europe GmbH DE-AR-000005685

Other devices from MEDICLUS Co., Ltd.

See all devices from MEDICLUS Co., Ltd. →

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