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BIOTRONIK SE & Co. KG

Germany·DE-MF-000005049

Last updated September 17, 2026

About

At BIOTRONIK, we engineer trusted, life-changing therapies through our advanced active implants in Cardiac Rhythm Management, Monitoring, and Neuromodulation, while providing cutting-edge solutions in Electrophysiology.

From the manufacturer's own website. Source

Information

Country: Germany
Address: 1, Woermannkehre, Berlin, Germany
Website: www.biotronik.com/
LinkedIn: linkedin.com/company/biotronik
Facebook: —
Email: [email protected]
Phone: +49 30 68905 0
PRRC Contact: Stephan Schwerzel
EUDAMED SRN: DE-MF-000005049
FDA FEI Number: 3002806500
DUNS Number: —

Catalogue (37)

Device	Model / Reference	Registries	Class	Status
PK-142 /2, 5m	362442	EUDAMED	Class I	Active
Sw Hmsc 3.65	496631	EUDAMED	Class III	Active
PK-128/2, 8m	339818	EUDAMED	Class I	Active
PK-82/1, 5m	128564	EUDAMED	Class I	Active
Qubic Stim - EP Heart Stimulator	396165	EUDAMED	Class IIb	Active
Sw Hmsc 3.66	498092	EUDAMED	Class III	Active
Selectra 3D-65-39	443629	EUDAMEDFDA UDI	Class III	Active
Selectra BIO2-45	375523	EUDAMEDFDA UDI	Class III	Active
Selectra BIO2-55	375524	EUDAMEDFDA UDI	Class III	Active
Selectra Amplatz 6.0-55	375520	EUDAMEDFDA UDI	Class III	Active
Selectra IC-50-59	392289	EUDAMEDFDA UDI	Class III	Active
Selectra 3D-40-32	443624	EUDAMEDFDA UDI	Class III	Active
Selectra Amplatz 6.0-45	375519	EUDAMEDFDA UDI	Class III	Active
Selectra MPH-55	375534	EUDAMEDFDA UDI	Class III	Active
Selectra Hook-55	375530	EUDAMEDFDA UDI	Class III	Active
Selectra Straight-55	375521	EUDAMEDFDA UDI	Class III	Active
Selectra Straight-45	375537	EUDAMEDFDA UDI	Class III	Active
Selectra 3D-55-32	443626	EUDAMEDFDA UDI	Class III	Active
Selectra 3D-65-32	443628	EUDAMEDFDA UDI	Class III	Active
Selectra Extended Hook-45	375527	EUDAMEDFDA UDI	Class III	Active
Selectra IC-90-59	392291	EUDAMEDFDA UDI	Class III	Active
Selectra Right-45	375535	EUDAMEDFDA UDI	Class III	Active
Selectra IC-90-69	392292	EUDAMEDFDA UDI	Class III	Active
Selectra 3D-65-42	451791	EUDAMEDFDA UDI	Class III	Active
Selectra 3D-55-39	443627	EUDAMEDFDA UDI	Class III	Active
Selectra MPH-45	375533	EUDAMEDFDA UDI	Class III	Active
Selectra Accessory Kit	375518	EUDAMEDFDA UDI	Class III	Active
Selectra IC-50-69	392290	EUDAMEDFDA UDI	Class III	Active
Selectra 3D-55-42	451790	EUDAMEDFDA UDI	Class III	Active
Selectra 3D-40-39	443625	EUDAMEDFDA UDI	Class III	Active
Selectra Hook-45	375529	EUDAMEDFDA UDI	Class III	Active
Selectra MPEP-45	375531	EUDAMEDFDA UDI	Class III	Active
Selectra Slitter	383119	EUDAMEDFDA UDI	Class I	Active
Selectra 3D-40-42	451789	EUDAMEDFDA UDI	Class III	Active
Selectra MPEP-55	375532	EUDAMEDFDA UDI	Class III	Active
Selectra Right-55	375536	EUDAMEDFDA UDI	Class III	Active
Selectra Extended Hook-55	375528	EUDAMEDFDA UDI	Class III	Active

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FDA Establishments (1)

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BIOTRONIK SE & Co. KG US