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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

ParaScout — IVDR Class A IVDR by Leven Vision B.V.

MD Atlas
Leven Vision B.V.

EUDAMED last updated this device on Mar 2, 2026

ParaScout

87208928786PSGW

On the marketIVDR Class A

Applicable legislation: IVDR [Regulation (EU) 2017/746 on in vitro diagnostic medical devices]
Organization name: Leven Vision B.V.
UDI-DI code: 08720892878601
Reference / catalog number: PS-100

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Manufacturer information

Organization name: Leven Vision B.V.
SRN: NL-MF-000051263
Manufacturer status: Active

Critical warnings

1 warning recorded — scroll inside the panel to see all entries.

CW999
The device includes warnings and limitations of use in the Instructions for Use, including restriction to professional laboratory users and clarification that results must be interpreted within the full clinical context.

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Market distribution

Primary placement in Netherlands; available across 1 country total.

Placed on the market in Netherlands; per-country availability dates not published.

Device identification

Trade name: ParaScout
UDI-DI code: 08720892878601
Basic UDI-DI: 87208928786PSGW
Reference / catalog number: PS-100
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: Standalone IVD software for analysis of digital microscopy images of stool samples to support detection and classification of parasitic structures in laboratory diagnostic workflows.
Additional information URL: https://leven.vision/ifu
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)08720892878601

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EMDN nomenclature code(s)

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

W0202050392LABORATORY INSTRUMENTS FOR MICROSCOPIC INVESTIGATIONS - IVD MEDICAL DEVICE SOFTWARE

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.