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Bioptimal Bipolar Pacing Catheter
EUDAMEDFDA 510(k)Class III (EU MDR)
Ref BP-0002-020Model BP2502-10 (EUROPE-Straight）Ref BP-0006-011Model BP2502CS-10（CROATIA)(PLUG-B)Ref BP-0005-003Model BPX2502-10 (EUROPE) (BIOTRONIK)Ref BP-0002-017Model BP2502-10(EUROPE)(PLUG-B)Ref BP-0002-009Model BP2502CS-10 (EUROPE)Ref BP-0002-006Model BP2502-10 (EUROPE)Ref BP-0002-019Model BPX2502-10 (EUROPE) (PLUG-B)Ref BP-0005-004Model BP2502-10 (EUROPE) (BIOTRONIK)
Identity
- Trade Name
- Bioptimal Bipolar Pacing Catheter EUDAMED
- Device Name
- Bioptimal Bipolar Pacing Catheter EUDAMEDBipolar Pacing Catheter EUDAMED
- Model / Reference
- BP2502-10 (EUROPE-Straight） EUDAMEDBP-0002-020 EUDAMEDBP2502CS-10（CROATIA)(PLUG-B) EUDAMEDBP-0006-011 EUDAMEDBPX2502-10 (EUROPE) (BIOTRONIK) EUDAMEDBP-0005-003 EUDAMEDBP2502-10(EUROPE)(PLUG-B) EUDAMEDBP-0002-017 EUDAMEDBP2502CS-10 (EUROPE) EUDAMEDBP-0002-009 EUDAMEDBP2502-10 (EUROPE) EUDAMEDBP-0002-006 EUDAMEDBPX2502-10 (EUROPE) (PLUG-B) EUDAMEDBP-0002-019 EUDAMEDBP2502-10 (EUROPE) (BIOTRONIK) EUDAMEDBP-0005-004 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08886483509818 EUDAMED08886483512474 EUDAMED08886483507418 EUDAMED08886483507166 EUDAMED08886483507111 EUDAMED08886483507098 EUDAMED08886483509627 EUDAMED08886483507425 EUDAMED
- Basic UDI-DI
- B-08886483509818 EUDAMEDB-08886483512474 EUDAMEDB-08886483507418 EUDAMEDB-08886483507166 EUDAMEDB-08886483507111 EUDAMEDB-08886483507098 EUDAMEDB-08886483509627 EUDAMEDB-08886483507425 EUDAMED
- EMDN Code
- C020201 TEMPORARY ENDOCARDIAL LEADS EUDAMED
Classification
- Device Class
- Class III EUDAMED
- Market of Registration
- Germany EUDAMEDGreece EUDAMED
Clinical & Handling
Sterile
Yes
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
Yes
EUDAMEDEUDAMED
Reprocessed
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Bioptimal Bipolar Pacing Catheter by Bioptimal International Pte. Ltd. — Class III — FDA_510K, MDD — listed in EUDAMED, FDA 510(k)
Authorization Coverage (2 countries)
Regulatory Authorizations
United States Active
FDA_510K
European Union Active
CE/MDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K242863 | Class III | Active |
| EUDAMED | European Union | CE/MDD | B-08886483509818 | Class III | Active |
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Manufacturer
- Manufacturer
- Bioptimal International PTE. LTD.
- EUDAMED SRN
- SG-MF-000010306
- Authorised Representative
- Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001
Sources (9)
- EUDAMED 299c0e70-83a1-4d27-af18-fa5640a74b74 61 fields · synced Aug 1, 2026
- EUDAMED c73da596-98da-43ab-a264-88e3fceba83a 61 fields · synced May 11, 2026
- EUDAMED f54f91ca-a90d-407f-9a34-e838ba50b759 61 fields · synced May 16, 2026
- EUDAMED 639e8c4e-bbad-4d6b-86a7-4e828de6355b 61 fields · synced May 17, 2026
- EUDAMED bd23d1b0-0ea0-44f6-b34d-0ed22d95f533 61 fields · synced May 18, 2026
- EUDAMED e1150793-5454-4a59-b2ea-d4bf478250ac 61 fields · synced May 18, 2026
- EUDAMED 9d0dd426-1216-4d63-bc64-826187ceb1ad 61 fields · synced May 18, 2026
- EUDAMED 28f569b0-23ee-440a-81c9-662e4cd7d93d 61 fields · synced May 18, 2026
- FDA 510(k) K242863 1 fields · synced May 18, 2026