EUDAMED last updated this device on Jul 21, 2026

AESKULISA® ssDNA-A

B-04250289500678

On the marketIVDD — General

Applicable legislation: —
Organization name: Aesku.Diagnostics GmbH & Co. KG
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 →: 04250289500678
Reference / catalog number: 3145

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.

AESKULISA® ssDNA-A is an IVDD-legacy in vitro diagnostic registered in EUDAMED. It is classified as IVDD — General. Manufactured by Aesku.Diagnostics GmbH & Co. KG. Placed on the EU market in Germany. Explore certificates, regulatory status and the EUDAMED record on MD Atlas.

Device identification

Trade name: AESKULISA® ssDNA-A
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 →: 04250289500678
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 →: B-04250289500678
Reference / catalog number: 3145
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 →: GS1

Classification

Risk category: IVDD — General
Applicable legislation: —
Status: On the market

Device details

Quantity: 1
Additional product description: AESKULISA® ssDNA-A is a solid phase enzyme immunoassay with human recombinant single-stranded DNA (ssDNA) for the quantitative and qualitative detection of IgA antibodies against ssDNA in human serum. Antibodies against ssDNA mainly recognize its basic compound, which is masked inside the helical structure of native DNA. The assay is a tool in the differential diagnosis of systemic lupus erythematosus (SLE).
Additional information URL: No additional information URL provided by the manufacturer.
Clinical sizes: No clinical sizes registered for this device.

UDI-PI traceability

Batch number
Expiration date
Manufacturing date
Serial number
Software identification

UDI-DI DataMatrix

Encoded

(01)04250289500678

EMDN nomenclature code(s)

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

W0102100106SS DNA - ANTIBODIES

Critical warnings

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

Consult instructions for use

Compliance flags

Safety

Direct marking

Regulatory

Sterilization

Lifecycle

New device

Market distribution

Primary placement in Germany; available across 22 countries total.

Country	On market since	Until
GermanyPrimary placement	—	Still on market
Austria	—	Still on market
Belgium	—	Still on market
Cyprus	—	Still on market
EL	—	Still on market
Spain	—	Still on market
Finland	—	Still on market
France	—	Still on market
Croatia	—	Still on market
Ireland	—	Still on market
Italy	—	Still on market
Liechtenstein	—	Still on market
Luxembourg	—	Still on market
Malta	—	Still on market
Netherlands	—	Still on market
Norway	—	Still on market
Poland	—	Still on market
Portugal	—	Still on market
Romania	—	Still on market
Slovenia	—	Still on market
Slovakia	—	Still on market
Türkiye	—	Still on market

Related searches

IVDD — General medical devices in EUDAMED

Device identification

Trade name: AESKULISA® ssDNA-A
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 →: 04250289500678
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 →: B-04250289500678
Reference / catalog number: 3145
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 →: GS1

Device details

Quantity: 1
Additional product description: AESKULISA® ssDNA-A is a solid phase enzyme immunoassay with human recombinant single-stranded DNA (ssDNA) for the quantitative and qualitative detection of IgA antibodies against ssDNA in human serum. Antibodies against ssDNA mainly recognize its basic compound, which is masked inside the helical structure of native DNA. The assay is a tool in the differential diagnosis of systemic lupus erythematosus (SLE).
Additional information URL: No additional information URL provided by the manufacturer.
Clinical sizes: No clinical sizes registered for this device.

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 22 countries total.

Country	On market since	Until
GermanyPrimary placement	—	Still on market
Austria	—	Still on market
Belgium	—	Still on market
Cyprus	—	Still on market
EL	—	Still on market
Spain	—	Still on market
Finland	—	Still on market
France	—	Still on market
Croatia	—	Still on market
Ireland	—	Still on market
Italy	—	Still on market
Liechtenstein	—	Still on market
Luxembourg	—	Still on market
Malta	—	Still on market
Netherlands	—	Still on market
Norway	—	Still on market
Poland	—	Still on market
Portugal	—	Still on market
Romania	—	Still on market
Slovenia	—	Still on market
Slovakia	—	Still on market
Türkiye	—	Still on market

AESKULISA® ssDNA-A

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

Related devices

Certificates

Certificates covering this device