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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

UROM01 — IVDD — General IVDD by Infogene, Lda.

MD Atlas
Infogene, Lda.

EUDAMED last updated this device on May 28, 2026

UROM01

B-infogene_CP

On the marketIVDD — General

Applicable legislation: IVDD [Directive 98/79/EC on in vitro diagnostic medical devices]
Organization name: Infogene, Lda.
UDI-DI code: D-infogene_CP
Reference / catalog number: UROM01

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View device family (Basic UDI)

Manufacturer information

Organization name: Infogene, Lda.
SRN: PT-MF-000047847
Manufacturer status: Active

Critical warnings

No critical warnings reported for this device.

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Market distribution

Primary placement in Portugal; available across 1 country total.

Country	On market since	Until
PortugalPrimary placement	Feb 8, 2018	Still on market

Device identification

Trade name: not provided
UDI-DI code: D-infogene_CP
Basic UDI-DI: B-infogene_CP
Reference / catalog number: UROM01
Issuing entity: EUDAMED

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: A non-invasive in vitro diagnostic device (IVD) intended for the detection and monitoring of recurrence of non-muscle-invasive bladder cancer (NMIBC) in patients previously diagnosed with bladder cancer. The device provides the components required for urine sample collection, DNA extraction and preparation from exfoliated bladder cells, and PCR-based detection of hotspot mutations in the TERTp and FGFR3 genes, which are highly prevalent in bladder cancer.
Additional information URL: https://u-monitor.eu/
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

D-infogene_CP

DataMatrix generation currently supports GS1-issued UDIs. HIBCC / ICCBBA support is coming.

EMDN nomenclature code(s)

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

W01060215BLADDER CANCER DETECTION / MONITORING

Compliance flags

Safety

Sterile

Single use

Direct marking

Regulatory

Sterilization

Lifecycle

New device

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Related devices

This device is not currently linked to any other device.

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.