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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

FOLLISCAN — Class IIa MDR by MIM Fertility Sp. z o.o.

MD Atlas
MIM Fertility Sp. z o.o.

EUDAMED last updated this device on May 8, 2026

FOLLISCAN

59050901989folliclesRZ

On the marketClass IIa

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: MIM Fertility Sp. z o.o.
UDI-DI code: 05905090198918
Reference / catalog number: FOLLISCAN

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View device family (Basic UDI)

Manufacturer information

Organization name: MIM Fertility Sp. z o.o.
SRN: PL-MF-000030821
Manufacturer status: Active

Critical warnings

No critical warnings reported for this device.

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Market distribution

Primary placement in Poland; available across 1 country total.

Country	On market since	Until
PolandPrimary placement	Aug 1, 2024	Feb 13, 2029

Device identification

Trade name: not provided
UDI-DI code: 05905090198918
Basic UDI-DI: 59050901989folliclesRZ
Reference / catalog number: FOLLISCAN
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: 1
Additional product description: The FOLLISCAN application is a medical device, software, based on artificial intelligence algorithms, providing information on the number and size of ovarian follicles, based on time-lapse videos (both 2D and 3D) of transvaginal ultrasound examinations, used in the ovulation monitoring process during ovarian ultrasound.
Additional information URL: No additional information URL provided by the manufacturer.
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)05905090198918

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UDI-PI DataMatrix

The compliance carrier: encodes the device identifier plus the production identifiers (lot, serial, dates) registered for this device.

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EMDN nomenclature code(s)

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

Z12080292GYNAECOLOGY AND FERTILITY TREATMENT 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

EMBRYOAID59050901989fertilityVSOn the market EMBRYOAID 2.059050901989fertilityVSOn the market FOLLISCAN 1.159050901989folliclesRZOn the market

Certificates

Certificate health across this manufacturer's portfolio.

1434-MDR-010/2024Issued
Quality management systemNotified body: 1434Expiry: Jul 31, 2029