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Our data is continuously updated and sourced from EUDAMED, the European database for medical devices and in vitro diagnostics.

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Organization name
UDI-DI code
Reference / catalog number

420000 — IVDR Class A IVDR by Aesku.Diagnostics GmbH…

MD Atlas
Aesku.Diagnostics GmbH & Co. KG

EUDAMED last updated this device on Mar 17, 2026

420000

42502895BLOTSAllergyCCD7D

On the marketIVDR Class A

Applicable legislation: IVDR [Regulation (EU) 2017/746 on in vitro diagnostic medical devices]
Organization name: Aesku.Diagnostics GmbH & Co. KG
UDI-DI code: 04250289513500
Reference / catalog number: 420000

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Manufacturer information

Organization name: Aesku.Diagnostics GmbH & Co. KG
SRN: DE-MF-000026925
Manufacturer status: Active

Critical warnings

2 warnings recorded — scroll inside the panel to see all entries.

CW010
EUDAMED did not publish a description for this code.
CW009
EUDAMED did not publish a description for this code.

Market distribution

Primary placement in Germany; available across 1 country total.

Placed on the market in Germany; per-country availability dates not published.

Device identification

Trade name: not provided
UDI-DI code: 04250289513500
Basic UDI-DI: 42502895BLOTSAllergyCCD7D
Reference / catalog number: 420000
Issuing entity: GS1

Classification

Risk category: IVDR Class A
Applicable legislation: IVDR [Regulation (EU) 2017/746 on in vitro diagnostic medical devices]
Status: On the market

Device details

Quantity: 1
Additional product description: —
Additional information URL: No additional information URL provided by the manufacturer.
Clinical sizes: No clinical sizes registered for this device.

EMDN nomenclature code(s)

W01029099IMMUNOCHEMISTRY REAGENTS - OTHER

Compliance flags

Safety

Sterile

Single use

Direct marking

Regulatory

Sterilization

Lifecycle

New device

UDI-PI traceability

Batch number
Expiration date
Manufacturing date
Serial number
Software identification

Related devices

421001B-04250289510400On the market REF.LIA-100042502895HELIAG5On the market REF.LIA-100042502895HELIAG5On the market REF.IOS-100042502895HELIOSGROn the market REF.IOS-100042502895HELIOSGROn the market

Certificates

No certificates registered for this manufacturer.

No certificate references this Basic UDI-DI, because: • It does not require a certificate, or • It only requires a certificate without a Basic UDI-DI reference (e.g. a QMS certificate), or • The required certificate(s) referencing this Basic UDI-DI have not been registered yet.