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Berlin Heart GmbH

Germany·DE-MF-000006521

Last updated September 17, 2026

Information

Country: Germany
Address: 10, Wiesenweg, Berlin, Germany
Website: www.berlinheart.de/
LinkedIn: —
Facebook: —
Email: [email protected]
Phone: +49 30 81872600
PRRC Contact: Hendrik Heinze
EUDAMED SRN: DE-MF-000006521
FDA FEI Number: 3004582654
DUNS Number: 328654384

Catalogue (22)

Device	Model / Reference	Registries	Class	Status
Arterial cannula for graft (set) for infants	CGRG-005	EUDAMED	Class IIb	Active
Graft-adapter cannula	C00P-001	EUDAMED	Class III	Active
Graft-adapter cannula for children	C00P-004	EUDAMED	Class III	Active
Venous cannula	1200651	EUDAMED	Class IIb	Active
Arterial cannula for graft (set) for children	CGRG-009	EUDAMED	Class IIb	Active
Venous cannula	1200650	EUDAMED	Class IIb	Active
Arterial cannula for graft (set)	CGRG-012	EUDAMED	Class IIb	Active
Venous cannula	1200652	EUDAMED	Class IIb	Active
Arterial cannula for graft (set) for small children	CGRG-006	EUDAMED	Class IIb	Active
Connecting set for cannulas and Cannula extension set	A09-012	EUDAMEDFDA UDI	Class IIa	Active
Connecting set for cannulas and Cannula extension set	A12-012	EUDAMEDFDA UDI	Class IIa	Active
Driving tube	L20H-002x01	EUDAMEDFDA UDI	Class I	Active
Driving tube	L20H-003x01	EUDAMEDFDA UDI	Class I	Active
Accessory set PU valves	T00L-002	EUDAMEDFDA UDI	Class I	Active
Stationary driving unit Ikus Rev. 2.1	D03I-001	EUDAMED	Class IIb	Active
EXCOR Active driving unit	1502200	EUDAMED	Class IIb	Active
Connecting set for cannulas and Cannula extension set	A12-012m	EUDAMED	Class IIa	Active
Connecting set for cannulas and Cannula extension set	A06-006m	EUDAMED	Class IIa	Active
Connecting set for cannulas and Cannula extension set	A09-009	EUDAMEDFDA UDI	Class IIa	Active
Connecting set for cannulas and Cannula extension set	A06-009	EUDAMEDFDA UDI	Class IIa	Active
Connecting set for cannulas and Cannula extension set	A09-012m	EUDAMED	Class IIa	Active
Connecting set for cannulas and Cannula extension set	A09-009m	EUDAMEDFDA UDI	Class IIa	Active

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FDA Establishments (1)

Establishments registered with the FDA under this company group, matched by name.

Berlin Heart, Inc. The Woodlands, TX · US FEI 3008454189