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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-1001-01 — IVDD — Self-testing IVDD by ExSeed Health ApS

MD Atlas
ExSeed Health ApS

EUDAMED last updated this device on May 8, 2026

EH-1001-01

B-05745000659029

On the marketIVDD — Self-testing

Applicable legislation: IVDD [Directive 98/79/EC on in vitro diagnostic medical devices]
Organization name: ExSeed Health ApS
UDI-DI code: 05745000659029
Reference / catalog number: EH-1001-01

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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	Jan 6, 2020	Dec 31, 2027

Device identification

Trade name: not provided
UDI-DI code: 05745000659029
Basic UDI-DI: B-05745000659029
Reference / catalog number: EH-1001-01
Issuing entity: GS1

Classification

Risk category: IVDD — Self-testing
Applicable legislation: IVDD [Directive 98/79/EC on in vitro diagnostic medical devices]
Status: On the market

Device details

Quantity: 1
Additional product description: ExSeed Home Sperm Test Kit is an optical device that, in connection with the ExSeed: Sperm & Fertility App, analyses direct and calculated quantitative measurements of human semen, including: • Sperm Concentration (Million/ml) • Sperm Motility (%) • Total Motile Sperm Count (Million) Additionally, the ExSeed Collection Cup enables the user to quantitatively measure Semen Volume (ml). The device does not provide a clinical diagnosis or a comprehensive evaluation of male fertility. The device is a self-test, intended for single-person, in a home setting. For in vitro diagnostic use only.
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-3001-015745000659EH03W7On 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.