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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

DZ9027SCSET — IVDR Class A IVDR by Immundiagnostik AG

MD Atlas
Immundiagnostik AG

EUDAMED last updated this device on Feb 18, 2026

DZ9027SCSET

4050598DVDrySpotPL

On the marketIVDR Class A

Applicable legislation: IVDR [Regulation (EU) 2017/746 on in vitro diagnostic medical devices]
Organization name: Immundiagnostik AG
UDI-DI code: 04050598016446
Reference / catalog number: DZ9027SCSET

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Manufacturer information

Organization name: Immundiagnostik AG
SRN: DE-MF-000020905
Manufacturer status: Active

Critical warnings

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

CW010
-
CW009
-

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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: 04050598016446
Basic UDI-DI: 4050598DVDrySpotPL
Reference / catalog number: DZ9027SCSET
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: The collection set is intended for safe sample collection by lay users for in vitro diagnostics of the specified parameters. The collection set is used for: • Collecting a blood sample as capillary blood from the fingertip • Applying the blood to a filter paper inside the dried blood carrier • Drying the blood sample for stabilization • Sending the dried blood samples to a professional medical laboratory for measurement of the parameters The collection set is an in vitro diagnostic device suitable for use by laypersons from 18 years old and is intended for single use.
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
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Software identification

EMDN nomenclature code(s)

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

A99DEVICES FOR ADMINISTRATION, WITHDRAWAL AND COLLECTION - OTHER

Compliance flags

Safety

Sterile

Single use

Direct marking

Regulatory

Sterilization

Lifecycle

New device

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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.