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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

NA (Centralized Lab Product) — IVDR Class C IVDR by Agendia N.V

MD Atlas
Agendia N.V

EUDAMED last updated this device on May 18, 2026

NA (Centralized Lab Product)

0850024841MammaprintK9

On the marketIVDR Class C

Applicable legislation: IVDR [Regulation (EU) 2017/746 on in vitro diagnostic medical devices]
Organization name: Agendia N.V
UDI-DI code: 00850024841321
Reference / catalog number: NA (Centralized Lab Product)

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View device family (Basic UDI)

Manufacturer information

Organization name: Agendia N.V
SRN: NL-MF-000011684
Manufacturer status: Active

Critical warnings

No critical warnings reported for this device.

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Market distribution

Primary placement in Netherlands; available across 1 country total.

Country	On market since	Until
NetherlandsPrimary placement		Still on market

Device identification

Trade name: not provided
UDI-DI code: 00850024841321
Basic UDI-DI: 0850024841MammaprintK9
Reference / catalog number: NA (Centralized Lab Product)
Issuing entity: GS1

Classification

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

Device details

Quantity: 1
Additional product description: MammaPrint® FFPE is a qualitative, non-automated in vitro diagnostic test, performed in a Agendia’s Diagnostic Service Laboratory, using the gene expression profile obtained from formalin-fixed paraffin embedded (FFPE) breast cancer tissue samples to assess a patient’s risk for distant metastasis within 5 years. MammaPrint provides prognostic information regarding patient’s risk of distant metastasis and prediction of the magnitude of systemic therapy benefit to guide treatment decisions in patients with breast cancer.
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)00850024841321

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UDI-PI DataMatrix

The compliance carrier: encodes the device identifier plus the production identifiers (lot, serial, dates) registered for this device.

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EMDN nomenclature code(s)

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

W05039099DEVICES FOR SAMPLES ANALYSES - 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.