EUDAMED last updated this device on Aug 12, 2026

Enamelize™

++EDELTD03BUDI070031HU

On the marketClass I

Applicable legislation: —
Organization name: Deltamed GmbH
Primary DI The Primary DI is the main UDI-DI a manufacturer designates as the principal identifier for a device in EUDAMED. View in glossary →: +EDEL9061010
Reference / catalog number: 906101

Regulatory classification unavailableThis product's Basic UDI record hasn't been published in EUDAMED yet. Classification and compliance details will appear automatically once EUDAMED publishes it.

Enamelize™ is an EU-regulated medical device registered in EUDAMED. It is classified as Class I. Manufactured by Deltamed GmbH. Placed on the EU market in Germany. Explore certificates, regulatory status and the EUDAMED record on MD Atlas.

Device identification

Trade name: Enamelize™
Primary DI The Primary DI is the main UDI-DI a manufacturer designates as the principal identifier for a device in EUDAMED. View in glossary →: +EDEL9061010
Basic UDI-DI The Basic UDI-DI is the main identifier that groups together all device variants of the same model — the regulatory "family" key. View in glossary →: ++EDELTD03BUDI070031HU
Reference / catalog number: 906101
UDI issuing entities Issuing entities are the organisations the European Commission has designated to assign Unique Device Identifiers under the EU's UDI system. View in glossary →: HIBCC

Classification

Risk category: Class I
Applicable legislation: —
Status: On the market

Device details

Quantity: 1
Additional product description: —
Additional information URL: https://cosmedent.ifu.dental/
Clinical sizes: 36 MU24

UDI-PI traceability

Batch number
Expiration date
Manufacturing date
Serial number
Software identification

UDI-DI DataMatrix

+EDEL9061010

DataMatrix generation currently supports GS1-issued UDIs. HIBCC / ICCBBA support is coming.

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EMDN nomenclature code(s)

European Medical Device Nomenclature — the EU product classification assigned to this device.

Q01010403DENTAL ABRASIVE AND POLISHING MATERIALS

Critical warnings

No critical warnings reported for this device.

Compliance flags

Safety

Direct marking

Regulatory

Sterilization

Lifecycle

New device

Market distribution

Primary placement in Germany; available across 11 countries total.

Country	On market since	Until
GermanyPrimary placement	—	Still on market
Austria	—	Still on market
Belgium	—	Still on market
Czechia	—	Still on market
Spain	—	Still on market
France	—	Still on market
Ireland	—	Still on market
Luxembourg	—	Still on market
Malta	—	Still on market
Portugal	—	Still on market
Slovakia	—	Still on market

Related searches

Class I medical devices in EUDAMED

Device identification

Trade name: Enamelize™
Primary DI The Primary DI is the main UDI-DI a manufacturer designates as the principal identifier for a device in EUDAMED. View in glossary →: +EDEL9061010
Basic UDI-DI The Basic UDI-DI is the main identifier that groups together all device variants of the same model — the regulatory "family" key. View in glossary →: ++EDELTD03BUDI070031HU
Reference / catalog number: 906101
UDI issuing entities Issuing entities are the organisations the European Commission has designated to assign Unique Device Identifiers under the EU's UDI system. View in glossary →: HIBCC

Compliance flags

Safety

Direct marking

Regulatory

Sterilization

Lifecycle

New device

Certificates

No certificates registered for this manufacturer.

Market distribution

Primary placement in Germany; available across 11 countries total.

Country	On market since	Until
GermanyPrimary placement	—	Still on market
Austria	—	Still on market
Belgium	—	Still on market
Czechia	—	Still on market
Spain	—	Still on market
France	—	Still on market
Ireland	—	Still on market
Luxembourg	—	Still on market
Malta	—	Still on market
Portugal	—	Still on market
Slovakia	—	Still on market

Enamelize™

Device identification

Classification

Device details

UDI-PI traceability

UDI-DI DataMatrix

EMDN nomenclature code(s)

Critical warnings

Compliance flags

Safety

Regulatory

Lifecycle

Market distribution

Related searches

Device identification

Classification

Device details

Manufacturer information

UDI-PI traceability

UDI-DI DataMatrix

EMDN nomenclature code(s)

Critical warnings

Compliance flags

Safety

Regulatory

Lifecycle

Certificates

Certificates covering this device

Related devices

Market distribution

Related searches

Manufacturer information

Certificates covering this device

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Certificates