Peleton
by Sieć Badawcza Łukasiewicz - Krakowski Instytut Technologiczny Poland EUDAMED
Ref 05904815540025, 05904815540018
EMDN Z12050701
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | NumberTNP/MDR/0045/555/2025 | Date5 Jan 2026 | StatusActive |
Coverage
- Active
- Not covered
European Union — CE/MDR Active
Certificates
- TNP/MDR/0045/555/2025 Amended
Quality management system EU MDR
- Notified body
- TUV NORD Polska Sp. z o.o 2274
- Issued
- 5 Jan 2026
- Expires
- 12 Dec 2028
- Reason
- Mnf data change
Specification
- Trade Name
- PeletonPeleton-Cardiv
- Device Name
- System PELETON-CARDIV
- Model / Reference
- 05904815540025, 05904815540018
- Primary DI / UDI-DI
- 05904815540025, 05904815540018
- Basic UDI-DI
- 59048155400_PELECARD4E
- Direct Marketing DI
- 0590481554002505904815540018
- EMDN Code
- Z12050701 Complete cardiography systems
- Device Class
- Class IIa
- Market of Registration
- Poland
Manufacturer details
- EUDAMED SRN
- PL-MF-000001669
Other devices from Sieć Badawcza Łukasiewicz - Krakowski Instytut Technologiczny
Properties & raw data
Show properties, registry sources and raw records
Other properties (12)
- Sterile: No
- Implantable: No
- Reusable: No
- Contains Latex: No
- Reprocessed: No
- CMR Substance: No
- Human-derived: No
- Human Tissues: No
- Animal Tissues: No
- Endocrine Disruptor: No
- Administering Medicine: No
- Incorporates Medicinal Product: No
Sources (2)
- EUDAMED 79b6fc5c-f77a-4b75-bb6b-c8bb344041c2
- EUDAMED 05904815540018|59048155400_PELECARD4E