Register on issued Certificates and Excerpts from the Register on R&TT Equipment Conformity
updated:
05/07/2024
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CSV file | Number | Document | Equipment category | Equipment manufacturer | Type/model designation | Additional data | |
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| 34540-233/20-7 | Certificate | Medicinski uređaj za praćenje stanja pacijenata kojima je ugrađen implantibilni uređaj za kontrolu rada srca | BIOTRONIK SE & Co. KG. | Cardio Messenger Smart 4G | More Less | |
| Additional data |
Applicant: HERMES-PHARMA DOO BEOGRAD Equipment brand: BIOTRONIK Issuance date: 09/24/2020 Valid until: 09/24/2023 Poništena, datum poništavanja: 09/25/2023 |
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| 34540-1668/14-5 | Certificate | ULP-AMI medicinski implantabilni kardioverter / defibrilator za magnetnu rezonantnu tomografiju sa / bez "MR uslovno" (ULP-AMI Implantable Cardioverter /Defibrillator System with/without a conditional intended use in a MRI environment) | Biotronik Se & Co. KG. | Iforia 5 DR-T, Iforia 5 HF-T, Iforia 5 VR-T, Iforia 5 VR-T DX, varijante modela MR conditional; Iforia 3 VR-T, Iforia 3 DR-T, Iforia 3 HF-T | More Less | |
| Additional data |
Applicant: HERMES SYSTEMS DOO BEOGRAD Equipment brand: Biotronik Issuance date: 01/20/2015 Valid until: 01/20/2018 Poništena, datum poništavanja: 01/21/2018 |
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| 34540-204/19-7 | Certificate | ULP-AMI implantabilni kardioverter - defibrilator (ULP-AIvII Implantable Cardioverter- Defibrillator) | Biotronik Se & Co. KG. | familija ICD-4200, modeli: Rivacor 3 VR-T, Rivacor 3 DR-T, Rivacor 3 HF-T, Rivacor 3 HF-T QP, Rivacor 5 VR-T, Rivacor 5 VR-T DX, Rivacor 5 DR-T, Rivacor 5 HF-T, Rivacor 5 HF-T QP, Rivacor 7 VR-T, Rivacor 7 VR-T DX, Rivacor 7 DR-T, Rivacor 7 HF-T, Rivacor 7 HF-T QP | More Less | |
| Additional data |
Applicant: HERMES-PHARMA doo Beograd Equipment brand: Biotronik Issuance date: 05/21/2019 Valid until: 05/21/2022 Poništena, datum poništavanja: 05/22/2022 |
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| 34540-1410/14-7 | Certificate | ULP-AMI medicinski implantabilni kardioverter / defibrilator sa funkcijom "MR uslovno" za magnetnu rezonantnu tomografiju (ULP-AMI Implantable Cardioverter /Defibrillator System with a conditional intended use in a MRI environment) | Biotronik Se & Co. KG. | Iforia 5 DR-T, Iforia 5 HF-T, Iforia 5 VR-T, Iforia 5 VR-T DX, varijante modela MR conditional | More Less | |
| Additional data |
Applicant: HERMES SYSTEMS DOO BEOGRAD Equipment brand: Biotronik Issuance date: 12/08/2014 Valid until: 12/08/2017 Poništena, datum poništavanja: 01/20/2015 |
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| 34540-236/21-5 | Certificate | ULP-AMI implantabilni kardioverter - defibrilator (ULP-AMI Implantable Cardioverter - Defibrillator) | Biotronik Se & Co. KG. | Intica Neo 7 VR-T, Intica Neo 5 VR-T, Intica Neo 7 VR-T DX, Intica Neo 5 VR-T DX, Intica Neo 7 DR-T, Intica Neo 5 DR-T, Intica Neo 7 HF-T, Intica Neo 5 HF-T, Intica Neo 7 HF-T QP, Intica Neo 5 HF-T QP | More Less | |
| Additional data |
Applicant: HERMES-PHARMA doo Beograd Equipment brand: Biotronik Issuance date: 12/07/2021 Valid until: 12/07/2024 |
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| 34540-240/21-4 | Certificate | Programer Renamic Neo (Renamic Neo programmer) | Biotronik Se & Co. KG. | Renamic Neo | More Less | |
| Additional data |
Applicant: HERMES-PHARMA doo Beograd Equipment brand: Biotronik Issuance date: 12/21/2021 Valid until: 12/21/2024 |
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| 34540-58/23-3 | Excerpt | ULP-AMI implantabilni kardioverter - defibrilator (ULP-AMI Implantable Cardioverter - Defibrillator) | Biotronik Se & Co. KG. | Intica Neo 7 VR-T, Intica Neo 5 VR-T, Intica Neo 7 VR-T DX, Intica Neo 5 VR-T DX, Intica Neo 7 DR-T, Intica Neo 5 DR-T, Intica Neo 7 HF-T, Intica Neo 5 HF-T, Intica Neo 7 HF-T QP, Intica Neo 5 HF-T QP | More Less | |
| Additional data |
Applicant: MEGAPHARM doo BEOGRAD Equipment brand: Biotronik Issuance date: 05/04/2023 Valid until: 12/07/2024 |
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| 34540-290/17-7 | Certificate | ULP-AMI pesmejker (ULP-AMI Pacemaker) | Biotronik Se & Co. KG. | Enticos 8 HF-T, Enticos 8 HF-T QP, Enticos 8 DR-T, Enticos 8 SR-T, Enticos 4 DR, Enticos 4 SR, Enticos 4 D, Enticos 4 S | More Less | |
| Additional data |
Applicant: HERMES SYSTEMS DOO BEOGRAD Equipment brand: Biotronik Issuance date: 08/09/2017 Valid until: 08/09/2020 Poništena, datum poništavanja: 08/10/2020 |
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| 34540-291/17-7 | Certificate | ULP-AMI pesmejker (ULP-AMI Pacemaker) | Biotronik Se & Co. KG. | Enitra 8 HF-T ProMRI, Enitra 8 HF-T QP proMRI, Enitra 8 DR-T ProMRI, Enitra 8 SR-T ProMRI, Enitra 6 DR-T ProMRI, Enitra 6 SR-T ProMRI, Enitra 6 DR ProMRI, Enitra 6 SR ProMRI | More Less | |
| Additional data |
Applicant: HERMES SYSTEMS DOO BEOGRAD Equipment brand: Biotronik Issuance date: 08/09/2017 Valid until: 08/09/2020 Poništena, datum poništavanja: 08/10/2020 |
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| 34540-59/23-3 | Excerpt | Programer Renamic Neo (Renamic Neo programmer) | Biotronik Se & Co. KG. | Renamic Neo | More Less | |
| Additional data |
Applicant: MEGAPHARM doo BEOGRAD Equipment brand: Biotronik Issuance date: 05/11/2023 Valid until: 12/21/2024 |
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| 34540-292/17-7 | Certificate | ULP-AMI implantabilni kardioverter defibrilator (ULP-AMI Implantable Cardioverter Defibrillator) | Biotronik Se & Co. KG. | Intica 7 HF-T, Intica 7 HF-T QP, Intica 7 DR-T, Intica 7 VR-T DX, Intica 7 VR-T, Intica 5 HF-T, Intica 5 HF-T QP, Intica 5 DR-T, Intica 5 VR-T DX, Intica 5 VR-T | More Less | |
| Additional data |
Applicant: HERMES SYSTEMS DOO BEOGRAD Equipment brand: Biotronik Issuance date: 08/09/2017 Valid until: 08/09/2020 Poništena, datum poništavanja: 08/10/2020 |
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| 34540-293/17-7 | Certificate | ULP-AMI implantabilni kardioverter defibrilator (ULP-AMI Implantable Cardioverter Defibrillator) | Biotronik Se & Co. KG. | Inlexa 7 HF-T, Inlexa 7 HF-T QP, Inlexa 7 DR-T, Inlexa 7 VR-T DX, Inlexa 7 VR-T, Inlexa 3 HF-T, Inlexa 3 HF-T QP, Inlexa 3 DR-T, Inlexa 3 VR-T | More Less | |
| Additional data |
Applicant: HERMES SYSTEMS DOO BEOGRAD Equipment brand: Biotronik Issuance date: 08/09/2017 Valid until: 08/09/2020 Poništena, datum poništavanja: 08/10/2020 |
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| 34540-433/16-6 | Certificate | Uređaj za programiranje i nadgledanje medicinskih implatanta vrlo male snage (ULP-AMI) i sa ugrađenim GSM900/DCS1800/UMTS2100 modulom (Programmers for Cardiac Implantable Devices and their external components) | BIOTRONIK SE & Co. KG | RENAMIC / Renamic, Renamic PGH, Renamic with H24 | More Less | |
| Additional data |
Applicant: HERMES SYSTEM DOO BEOGRAD Equipment brand: BIOTRONIK Issuance date: 09/06/2016 Valid until: 09/06/2019 Poništena, datum poništavanja: 09/07/2019 |
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| 34540-1118/15-5 | Certificate | Aktivni medicinski uređaj male snage Implantable Pacemakers | BIOTRONIK SE & Co. KG | Etrinsa 6 SR, Etrinsa 6 SR-T, Etrinsa 6 DR-T, Etrinsa 8 SR-T, Etrinsa 8 DR-T, Etrinsa 8 HF-T | More Less | |
| Additional data |
Applicant: HERMES SYSTEM DOO BEOGRAD Equipment brand: BIOTRONIK Issuance date: 12/09/2015 Valid until: 12/09/2018 Poništena, datum poništavanja: 01/12/2016 |
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| 34540-39/19-10 | Certificate | Telemonitoring sistem (Telemonitoring System) | BIOTRONIK SE & Co. KG | CardioMessenger Smart 2G | More Less | |
| Additional data |
Applicant: HERMES-PHARMA doo Beograd Equipment brand: Biotronik Issuance date: 04/01/2019 Valid until: 04/01/2022 Poništena, datum poništavanja: 04/02/2022 |
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| 34540-35/24-7 | Certificate | Medicinski uređaj za praćenje stanja pacijenata kojima je ugrađen implantibilni uređaj za kontrolu rada srca (CardioMessenger Smart 4G) | BIOTRONIK SE & Co. KG | CardioMessenger Smart 4G | More Less | |
| Additional data |
Applicant: MEGAPHARM doo BEOGRAD Equipment brand: BIOTRONIK Issuance date: 04/04/2024 Valid until: 04/04/2027 |
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| 34540-374/19-8 | Certificate | Uređaj za programiranje i nadgledanje medicinskih implatanta vrlo male snage (ULP-AMI) i sa ugrađenim GSM900/DCS1800/UMTS2100 modulom (Programmers for Cardiac Implantable Devices and their external components) | BIOTRONIK SE & Co. KG | RENAMIC / Renamic, Renamic PGH, Renamic with H24 | More Less | |
| Additional data |
Applicant: HERMES-PHARMA doo Beograd Equipment brand: BIOTRONIK Issuance date: 09/10/2019 Valid until: 09/10/2022 Poništena, datum poništavanja: 09/11/2022 |
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| 34540-375/19-7 | Certificate | Korisnički uređaj za bežični prenos podataka sa implantabilnim sistemima za praćenje i snimanje rada srca (User Device) | BIOTRONIK SE & Co. KG | Remote Assistant III | More Less | |
| Additional data |
Applicant: HERMES-PHARMA doo Beograd Equipment brand: Biotronik Issuance date: 10/14/2019 Valid until: 10/14/2022 Poništena, datum poništavanja: 10/15/2022 |
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| 34540-376/19-4 | Certificate | Implantabilni sistemi za praćenje i snimanje rada srca (Implantable Cardiac Monitoring and Recording Systems) | BIOTRONIK SE & Co. KG | BIOMONITOR III | More Less | |
| Additional data |
Applicant: HERMES-PHARMA doo Beograd Equipment brand: Biotronik Issuance date: 10/14/2019 Valid until: 10/14/2022 Poništena, datum poništavanja: 02/06/2022 |
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| 34540-241/21-4 | Certificate | Implantabilni monitor rada srca (Implantable Cardiac Monitor) | BIOTRONIK SE & Co. KG | BIOMONITOR IIIm | More Less | |
| Additional data |
Applicant: HERMES-PHARMA doo Beograd Equipment brand: BIOTRONIK Issuance date: 12/23/2021 Valid until: 12/23/2024 Poništena, datum poništavanja: 02/06/2022 |
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