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Organization name
UDI-DI code
Reference / catalog number

SwimCount™ Harvester — Class IIa MDR by MotilityCount ApS

MD Atlas
MotilityCount ApS

EUDAMED last updated this device on Mar 6, 2026

SwimCount™ Harvester

5745000420SWHARVESTERF6

On the marketClass IIa

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: MotilityCount ApS
UDI-DI code: 05745000420049
Reference / catalog number: 010917

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Manufacturer information

Organization name: MotilityCount ApS
SRN: DK-MF-000001507
Manufacturer status: Active

Market distribution

Primary placement in Denmark; available across 1 country total.

Country	On market since	Until
DenmarkPrimary placement	Sep 17, 2024	Still on market

Device identification

Trade name: SwimCount™ Harvester
UDI-DI code: 05745000420049
Basic UDI-DI: 5745000420SWHARVESTERF6
Reference / catalog number: 010917
Issuing entity: GS1

Classification

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

Device details

Quantity: 5
Additional product description: The device is a Sperm Purification Device that separates the PMSCs from the rest of the semen sample. The purified sample is used in the treatment of infertile couples by In-Vitro Fertilisation (IVF), Intra Cytoplasmic Sperm Injection (ICSI) or Intrauterine Insemination (IUI).
Additional information URL: No additional information URL provided by the manufacturer.
Clinical sizes: No clinical sizes registered for this device.

EMDN nomenclature code(s)

U080207CONTAINERS FOR PREPARATION OF BIOLOGICAL MATERIAL FOR ASSISTED REPRODUCTION

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

UDI-PI traceability

Batch number
Expiration date
Manufacturing date
Serial number
Software identification

Related devices

SwimCount™ Harvester5745000420SWHARVESTERF6On 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.