← Back to catalogue

ONE COAT 7 UNIVERSAL Refill 1 x 5 ml

EUDAMED

Class IIa (EU MDR)

Ref 60019539Model ONE COAT 7 UNIVERSAL

by Dent4You AG

Identity

Trade Name
ONE COAT 7 UNIVERSAL Refill 1 x 5 ml EUDAMED
Model / Reference
ONE COAT 7 UNIVERSAL EUDAMED
60019539 EUDAMED

Identifiers

Primary DI / UDI-DI
07630243601493 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 Refill 1 x 5 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

Is this your device? Claim it to add documentation and request validation.

Manufacturer

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

Sources (1)

  • EUDAMED e3a6ee5e-97f0-4136-a358-25bbffe07f46 61 fields · synced Sep 18, 2026