Spike Flow Bipolar Pacing Catheter
by Bioptimal International PTE. LTD. EUDAMED
Active
Ref BP2502-10 / BP-0002-023 / 12065, BP-0002-023Model BP2502-10 / BP2502CS-10 / BPX2502-10 / BPX2502CS-10, BP2502-10
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDD | Number888648350907SB | Date8 Sep 2026 | StatusActive |
| European Union | CE/MDR | Number888648350907SB | Date8 Sep 2026 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
European Union — CE/MDD, CE/MDR Active
Certificates
- 2283440CE01 Issued
Quality management system EU MDR
- Notified body
- Notified body 0344
- Issued
- 24 Mar 2026
- Expires
- 1 Mar 2031
- 2283440TD01 Amended
Technical documentation EU MDR
- Notified body
- Notified body 0344
- Issued
- 9 Apr 2026
- Expires
- 1 Mar 2031
- Reason
- Mnf data change
Specification
- Trade Name
- Spike Flow Bipolar Pacing CatheterSpike Flow
- Device Name
- Bipolar Pacing Catheter
- Model / Reference
- BP2502-10 / BP2502CS-10 / BPX2502-10 / BPX2502CS-10, BP2502-10 / BP-0002-023 / 12065, BP2502-10, BP-0002-023
- Primary DI / UDI-DI
- 08886483531628
- Basic UDI-DI
- 888648350907SB, B-08886483531628
- EMDN Code
- C020201 Temporary endocardial leads
- Device Class
- Class III
- Market of Registration
- Italy
Manufacturer details
- EUDAMED SRN
- SG-MF-000010306
- Authorised representative
- CMC Medical Devices & Drugs SL ES-AR-000000293
Other devices from Bioptimal International Pte. Ltd.
Properties
Other properties (11)
- Implantable: No
- Reusable: No
- Reprocessed: No
- CMR Substance: No
- Human-derived: No
- Human Tissues: No
- Animal Tissues: No
- Endocrine Disruptor: No
- Administering Medicine: No
- Measuring Function: No
- Incorporates Medicinal Product: No