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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

EH-3001-01 — IVDR Class A IVDR by ExSeed Health ApS

MD Atlas
ExSeed Health ApS

EUDAMED last updated this device on May 8, 2026

EH-3001-01

5745000659EH03W7

On the marketIVDR Class A

Applicable legislation: IVDR [Regulation (EU) 2017/746 on in vitro diagnostic medical devices]
Organization name: ExSeed Health ApS
UDI-DI code: 00574500065918
Reference / catalog number: EH-3001-01

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Manufacturer information

Organization name: ExSeed Health ApS
SRN: DK-MF-000025034
Manufacturer status: Active

Critical warnings

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

CW010
EUDAMED did not publish a description for this code.

Market distribution

Primary placement in Denmark; available across 1 country total.

Country	On market since	Until
DenmarkPrimary placement	Nov 20, 2024	Jan 1, 2030

Device identification

Trade name: not provided
UDI-DI code: 00574500065918
Basic UDI-DI: 5745000659EH03W7
Reference / catalog number: EH-3001-01
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: The ExSeed CASA Lite Human Semen Analyzer is an In Vitro Diagnostic Instrument used with ExSeed Sample Slides and the ExSeed: Clinic App for human semen analysis. It is a digital microscope which provides direct and calculated quantitative measurements for: 1. Sperm concentration (Million/mL) 2. Total motility (PR+NP, %) - Progressive motility (%) - Non-Progressive motility (%) 3. Sperm morphology (Normal forms, %) The subject device is an in-vitro diagnostic system intended for human semen analysis in healthcare professional settings to evaluate male fertility. Please note that subject device does not provide a comprehensive evaluation of a male's fertility status.
Additional information URL: No additional information URL provided by the manufacturer.
Clinical sizes: No clinical sizes registered for this device.

EMDN nomenclature code(s)

W02020199CELL COUNTING INSTRUMENTS - OTHER

Compliance flags

Safety

Sterile

Single use

Direct marking

Regulatory

Sterilization

Lifecycle

New device

UDI-PI traceability

Batch number
Expiration date
Manufacturing date
Serial number
Software identification

Related devices

EH-1001-01B-05745000659029On 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.