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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

PCaVision — Class IIb MDR by Angiogenesis Analytics…

MD Atlas
Angiogenesis Analytics B.V.

EUDAMED last updated this device on Nov 21, 2025

PCaVision

0872089PCaVisionSW48

On the marketClass IIb

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: Angiogenesis Analytics B.V.
UDI-DI code: 08720892067814
Reference / catalog number: PCaVision

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View device family (Basic UDI)

Manufacturer information

Organization name: Angiogenesis Analytics B.V.
SRN: NL-MF-000033108
Manufacturer status: Active

Critical warnings

No critical warnings reported for this device.

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Market distribution

Primary placement in Netherlands; available across 2 countries total.

Country	On market since	Until
NetherlandsPrimary placement		Still on market
Germany		Still on market

Device identification

Trade name: not provided
UDI-DI code: 08720892067814
Basic UDI-DI: 0872089PCaVisionSW48
Reference / catalog number: PCaVision
Issuing entity: GS1

Classification

Risk category: Class IIb
Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Status: On the market

Device details

Quantity: 1
Additional product description: PCaVision is a Clinical Decision Support System to be used by a qualified healthcare professional based on a combination of B-mode, Shear Wave Elastography, and Contrast-Enhanced US scans to support in the diagnosis of suspected clinically significant prostate cancer lesions.
Additional information URL: https://www.pcavision.com/
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)08720892067814

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EMDN nomenclature code(s)

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

Z11049092VARIOUS ULTRASOUND INSTRUMENTS - MEDICAL DEVICE SOFTWARE

Compliance flags

Safety

Sterile

Single use

Contains latex

Reprocessed single-use

Direct marking

Substances

CMR substance

Endocrine disruptor

Regulatory

Annex XVI applicable

Sterilization

Lifecycle

New device

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Related devices

PCaVision Probe Fixture0872089PCaVisionFIXJ4On 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.