EUDAMED last updated this device on Aug 11, 2026

3Delta Etemp A2

++EDELTD03BUDI030022GF

On the marketClass IIa

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 →: +EDEL16110200
Reference / catalog number: 1611020

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.

3Delta Etemp A2 is an EU-regulated medical device registered in EUDAMED. It is classified as Class IIa. 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: 3Delta Etemp A2
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 →: +EDEL16110200
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 →: ++EDELTD03BUDI030022GF
Reference / catalog number: 1611020
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 IIa
Applicable legislation: —
Status: On the market

Device details

Quantity: 1
Additional product description: —
Additional information URL: https://deltamed.ifu.dental/
Clinical sizes: 1000 MU24

UDI-PI traceability

Batch number
Expiration date
Manufacturing date
Serial number
Software identification

UDI-DI DataMatrix

+EDEL16110200

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.

Q01010103DENTAL RESTORATIVE COMPOSITES

Critical warnings

1 warning recorded — scroll inside the panel to see all entries.

H317 – May cause an allergic skin reaction.

Compliance flags

Safety

Direct marking

Regulatory

Sterilization

Lifecycle

New device

Market distribution

Primary placement in Germany; available across 9 countries total.

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

Related searches

Class IIa medical devices in EUDAMED

Device identification

Trade name: 3Delta Etemp A2
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 →: +EDEL16110200
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 →: ++EDELTD03BUDI030022GF
Reference / catalog number: 1611020
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 9 countries total.

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

3Delta Etemp A2

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

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Market distribution

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Manufacturer information

Certificates covering this device

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Certificates