EU → North America Device Access

FertiPro

BE-MF-000000313 · Belgium · Beernem

FertiPro is registered in the European database on medical devices as a manufacturer, with 61 devices declared. It has a similarly named entry in the FDA register that we have not verified.

What this manufacturer declares

Class IIa16

Most frequent device types declared: DRDB_1, DRDP_0002, EPI_PLUS, FRUCTO, IB_TUB.

Among these devices, 13 are declared sterile.

Devices declared under this manufacturer

Showing 12 of 61 declared devices.

Catalogue references include EPI_PLUS_3, EPI_PLUS_6, LEUCOP3, MINOIL500, MINOIL500P, SPMA_C.

European nomenclature codes declared: U08020502, W01030708, W01010199, W0102109013, W01010211, W01030702.

United States market access

FDA establishment registerSimilar name found — unverified
Matched entryFERTIPRO N.V. (BE) · FDA 3003272500
Devices in EUDAMED61
Country of registrationBelgium

⚠️ A similar name exists; we do not assert it is the same company — why.

Device-level evidence

Devices with a numeric GTIN61
Found in the U.S. device database39
Share63.9 %

Canadian market access

Health Canada licence listingSimilar name found — unverified
Matched entryFERTIPRO N.V.

⚠️ A similar name exists; unverified — why.

What it holds in Canada

Licences on record11
Currently active0
Class 2 devices11
First licensed2004-05-21

Licence types: Device Family (8), Test Kit (2), Single Device (1).

Licensed under: SIL-SELECT PLUS, SPERMFREEZE, FERTICULT FLUSHING MEDIUM, HOS TEST (HYPO-OSMOTIC SWELLING TEST), SPERMMAR IGG, SPERMMAR IGA.

Other manufacturers in Belgium

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