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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

HER2-RoI — IVDD — General IVDD by Mindpeak GmbH

MD Atlas
Mindpeak GmbH

EUDAMED last updated this device on May 21, 2026

HER2-RoI

B-04262392420040

On the marketIVDD — General

Applicable legislation: IVDD [Directive 98/79/EC on in vitro diagnostic medical devices]
Organization name: Mindpeak GmbH
UDI-DI code: 04262392420040
Reference / catalog number: HER2-RoI

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Manufacturer information

Organization name: Mindpeak GmbH
SRN: DE-MF-000031982
Manufacturer status: Active

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TE426239242TES3On the market ER-PR-RoIB-04262392420033On the market Ki-67-RoIB-04262392420071On the market Ki-67-HSB-04262392420064On the market AICB-04262392420095On 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.

Market distribution

Primary placement in Germany; available across 1 country total.

Country	On market since	Until
GermanyPrimary placement		Still on market

Device identification

Trade name: not provided
UDI-DI code: 04262392420040
Basic UDI-DI: B-04262392420040
Reference / catalog number: HER2-RoI
Issuing entity: GS1

Classification

Risk category: IVDD — General
Applicable legislation: IVDD [Directive 98/79/EC 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)

W02069092VARIOUS SAMPLE PROCESSING INSTRUMENTS - IVD MEDICAL DEVICE SOFTWARE

Compliance flags

Safety

Sterile

Single use

Direct marking

Regulatory

Sterilization

Lifecycle

New device

UDI-PI traceability

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Manufacturing date
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Software identification