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ONE COAT 7 UNIVERSAL Single Dose 50 x 0.1 ml

EUDAMED

Class IIa (EU MDR)

Ref 60019540Model ONE COAT 7 UNIVERSAL

by Dent4You AG

Identity

Trade Name
ONE COAT 7 UNIVERSAL Single Dose 50 x 0.1 ml EUDAMED
Model / Reference
ONE COAT 7 UNIVERSAL EUDAMED
60019540 EUDAMED

Identifiers

Primary DI / UDI-DI
07630243601509 EUDAMED
Basic UDI-DI
76303929COMP2007554 EUDAMED
EMDN Code
Q01010104 DENTAL BONDING AGENTS EUDAMED

Classification

Device Class
Class IIa EUDAMED
Market of Registration
Germany EUDAMED

Clinical & Handling

Sterile

No

EUDAMED

Implantable

Yes

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

Category: Dentine bonding agent/set

ONE COAT 7 UNIVERSAL Single Dose 50 x 0.1 ml by Dent4You AG — Class IIa — MDR — listed in EUDAMED — regulatory data on deviCERTS

Similar devices

Also classified as Dentine bonding agent/set.

Authorization Coverage (European Union — 27 member states)

Regulatory Authorizations

European Union Active

CE/MDR

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Manufacturer

Manufacturer
Dent4You AG
EUDAMED SRN
CH-MF-000028926
Authorised Representative
Dent4you GmbH DE-AR-000006093

Sources (1)

  • EUDAMED 47b089f2-8c84-4ee4-b1d6-af142df30b33 61 fields · synced Jun 18, 2026