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Boule Medical AB

Sweden·SE-MF-000001911

Last updated September 17, 2026

Information

Country: Sweden
Address: 7, Fagerstagatan, Spånga, Sweden
Website: www.boule.com
LinkedIn: —
Facebook: —
Email: [email protected]
Phone: +4687447700
PRRC Contact: Niklas Lundqvist
EUDAMED SRN: SE-MF-000001911
FDA FEI Number: 3004008703
DUNS Number: 354417933

Catalogue (33)

Device	Model / Reference	Registries	Class	Status
Medonic M51-L2 Lyse	Medonic M51-L2 Lyse, 500mL	FDA UDI	Class I	Active
Medonic M51-D Diluent	Medonic M51-D Diluent, 20L	FDA UDI	Class I	Active
Medonic M-series	M16C US	FDA UDI	Class II	Active
Swelab Lumi-D Diluent	Swelab Lumi-D Diluent 20L	FDA UDI	Class I	Active
Medonic M51-L1 Lyse	Medonic M51-L1 Lyse, 200mL	FDA UDI	Class I	Active
Swelab Lumi-L1 Lyse	Swelab Lumi-L1 Lyse 200mL	FDA UDI	Class I	Active
Medonic M-series	M16M US	FDA UDI	Class II	Active
Boule EasyCleaner	Boule EasyCleaner, 50ml	FDA UDI	Class I	Active
Medonic M-series	M16S BD ABR US	FDA UDI	Class II	Active
Medonic M-series	M16 US	FDA UDI	Class II	Active
Swelab Lumi-L2 Lyse	Swelab Lumi-L2 Lyse, 500mL	FDA UDI	Class I	Active
Medonic M-series M32 M	1420022	EUDAMED	Class B	Active
Medonic Ca620/530 Hematology Analyzer	K032214	FDA 510(k)	Class II	Active
Swelab Alfa Plus Sampler BD AR	1420046	EUDAMED	Class B	Active
Swelab Alfa Plus Basic	1420041	EUDAMED	Class B	Active
Medonic M-series Diluent, RFID	1504460	EUDAMED	Class A	Active
Swelab AlfaLyse, RFID	1504463	EUDAMED	Class A	Active
Swelab Alfa Plus Cap AR	1420044	EUDAMED	Class B	Active
Swelab Alfa ComboPack, RFID	1504464	EUDAMED	Class A	Active
Swelab Alfa Plus Standard	7350040791189	EUDAMED	Class B	Active
Swelab Alfa ComboPack 200	1504127	EUDAMED	Class A	Active
Medonic M-series Lyse, 5L	1504123	EUDAMED	Class A	Active
Swelab AlfaLyse, 900 cycles	1504125	EUDAMED	Class A	Active
Medonic M-series M32 B	1420021	EUDAMED	Class B	Active
Micro pipette, plastic EDTA 1x100	1070039	EUDAMEDFDA UDI	Class A	Active
Swelab AlfaDiluent, 900 cycles	1504124	EUDAMED	Class A	Active
Medonic M-serie Diluent 20L	1504122	EUDAMED	Class A	Active
Medonic M-series M32 S BD AR	1420026	EUDAMED	Class B	Active
Medonic M-series Dual-pack	1504128	EUDAMED	Class A	Active
Medonic M-serie DualPack, RFID	1504465	EUDAMED	Class A	Active
Medonic M-series Lyse, RFID	1504461	EUDAMED	Class A	Active
Medonic M-series M32 C AR	1420024	EUDAMED	Class B	Active
Swelab AlfaDiluent, RFID	1504462	EUDAMED	Class A	Active

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