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Q-Temp Clear Auto Mix Bulk Kit

EUDAMED

Class IIa (EU MDR)

Ref 100015CLRORef 100014CLRef 100015CL

by B.J.M. Laboratories Ltd.

Identity

Trade Name
Q-TEMP CLEAR AUTO MIX BULK KIT EUDAMED
Device Name
Long Term Temporary Resin Cement EUDAMED
Model / Reference
100015CLRO EUDAMED
100014CL EUDAMED
100015CL EUDAMED

Identifiers

Primary DI / UDI-DI
07290115053098 EUDAMED
07290115053937 EUDAMED
07290115053920 EUDAMED
Basic UDI-DI
72901150510001495 EUDAMED
Unit of Use DI
07290115053296 EUDAMED
EMDN Code
Q0101010203 TEMPORARY DENTAL CEMENTS EUDAMED

Classification

Device Class
Class IIa EUDAMED
Market of Registration
Belgium EUDAMED

Clinical & Handling

Sterile

No

EUDAMED

Implantable

No

EUDAMED

Reusable

No

EUDAMED

Contains Latex

No

EUDAMED

Reprocessed

No

EUDAMED

CMR Substance

No

EUDAMED

Human-derived

No

EUDAMED

Human Tissues

No

EUDAMED

Animal Tissues

No

EUDAMED

Endocrine Disruptor

No

EUDAMED

Administering Medicine

No

EUDAMED

Measuring Function

No

EUDAMED

Incorporates Medicinal Product

No

EUDAMED

Q-Temp Clear Auto Mix Bulk Kit by B.J.M. Laboratories Ltd. — Class IIa — MDR — listed in EUDAMED — regulatory data on deviCERTS

Authorization Coverage (European Union — 27 member states)

Regulatory Authorizations

European Union Active

CE/MDR

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Manufacturer

EUDAMED SRN
IL-MF-000034121
Authorised Representative
Obelis s.a. BE-AR-000000106

Sources (3)

  • EUDAMED 40becca3-4034-4fea-803c-f579f803ee0e 61 fields · synced Jul 24, 2026
  • EUDAMED 1e2e8917-4ead-4007-aa0f-37ff38fd0366 61 fields · synced May 17, 2026
  • EUDAMED d17c9cdc-3e32-4ac2-98f8-daf3c983550f 61 fields · synced May 19, 2026