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Sign in to claim this brandWhat BIOTRONIK SE & Co. KG makes
The company manufactures endocardial defibrillation leads, including models designed for MRI compatibility, as well as coronary venous and septal pacing leads for cardiac rhythm management. Their portfolio also includes vascular catheter stylets, implantable defibrillators for single-chamber and cardiac resynchronization therapy, and reusable electrical connection cables. Additional offerings encompass patient health record information systems and specialized tools like a slitter for lead production.
These devices fall under FDA device classes I, II, and III, with most entries listed in the FDA’s Unique Device Identifier (UDI) database. The company operates primarily in the United States, where its products are subject to U.S. regulatory requirements for medical devices.
Written from this company's registered devices by an AI model, and not verified by a human reviewer.
Information
- Country
- US
- Address
- —
- Website
- biotronik.com
- —
- —
- [email protected]
- Phone
- +1(888)345-0374
- PRRC Contact
- —
- EUDAMED SRN
- —
- FDA FEI Number
- —
- DUNS Number
- 315620229
Catalogue (541)
Page 2 of 11| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Solvia Rise DR-T | 460227 | FDA UDI | Class III | Active |
| Ilesto 5 VR-T | 383582 | FDA UDI | Class III | Unknown |
| Plexa ProMRI | S DX 65/15 | FDA UDI | Class III | Active |
| Celerity | Pilot 85 | FDA UDI | Class III | Active |
| Rivacor 5 VR-T DX DF4 ProMRI | 429564 | FDA UDI | Class III | Active |
| Iperia 5 DR-T | 392420 | FDA UDI | Class III | Unknown |
| Dh Df4 | 379137 | FDA UDI | Class III | Active |
| Psw | 1804.U | FDA UDI | Class III | Unknown |
| Volta | 1CR 60 | FDA UDI | Class III | Active |
| Home Monitoring Service Center | 3.61 | FDA UDI | Class III | Active |
| Home Monitoring Service Center | 3.43 | FDA UDI | Class III | Unknown |
| Home Monitoring Service Center | 3.40 | FDA UDI | Class III | Active |
| Intica Neo 5 HF-T QP DF-1 IS4 ProMRI | 429566 | FDA UDI | Class III | Active |
| Itrevia 7 VR-T DX DF-1 | 393037 | FDA UDI | Class III | Unknown |
| LV-Kit | 85 | FDA UDI | Class III | Active |
| Celerity | 3D 75 | FDA UDI | Class III | Active |
| Psw | 1507.U | FDA UDI | Class III | Unknown |
| Tilda R 45 US | 382884 | FDA UDI | Class III | Active |
| Estella SR-T | 371200 | FDA UDI | Class III | Unknown |
| Epyra 6 SR-T | 394937 | FDA UDI | Class III | Unknown |
| Intica 7 VR-T DX DF-1 ProMRI | 404633 | FDA UDI | Class III | Active |
| Bk-Is4/Df4 | 395399 | FDA UDI | Class III | Active |
| Psw | 2204.U | FDA UDI | Class III | Unknown |
| Intica Neo 7 VR-T DF-1 ProMRI | 429560 | FDA UDI | Class III | Active |
| S 65-E | 344044 | FDA UDI | Class II | Active |
| Edora 8 DR-T | 407145 | FDA UDI | Class III | Active |
| Home Monitoring Service Center | 3.28 | FDA UDI | Class III | Active |
| PK Electrode Clip | 340293 | FDA UDI | Class III | Active |
| Protego DF-1 | TD 65/18 | FDA UDI | Class III | Unknown |
| Amvia Edge DR-T | 460163 | FDA UDI | Class III | Active |
| Iforia 5 DR-T | 383569 | FDA UDI | Class III | Unknown |
| Resilience | 75 | FDA UDI | Class III | Active |
| Psw | 1304.U | FDA UDI | Class III | Unknown |
| PK-222 US/2, 8m | 335281 | FDA UDI | Class III | Active |
| Celerity | 2D 75 | FDA UDI | Class III | Active |
| S 53-J | 107237 | FDA UDI | Class II | Active |
| Tilda R 53 US | 382889 | FDA UDI | Class III | Active |
| Dextrus | 4136 | FDA UDI | Class III | Active |
| CardioMessenger | Smart 3G | FDA UDI | Class III | Active |
| Rivacor 5 HF-T DF4 IS-1 ProMRI | 429562 | FDA UDI | Class III | Active |
| Intica 7 HF-T DF-1 IS-1 ProMRI | 404627 | FDA UDI | Class III | Active |
| PatientApp 2.8 | 484448 | FDA UDI | Class I | Active |
| Home Monitoring Service Center | 3.48 | FDA UDI | Class III | Unknown |
| Neo | 2302.U | FDA UDI | Class III | Unknown |
| Iperia 5 HF-T QP | 402658 | FDA UDI | Class III | Unknown |
| Sentus ProMRI OTW QP L-75 | 401182 | FDA UDI | Class III | Active |
| Ilesto 5 VR-T DX | 383596 | FDA UDI | Class III | Unknown |
| Ilesto 7 HF-T | 383546 | FDA UDI | Class III | Unknown |
| PK-222-L ECG Cable US | 429748 | FDA UDI | Class III | Active |
| Kainox VCS 60 | 124325 | FDA UDI | Class III | Active |
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