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Bioptimal Bipolar Pacing Catheter
EUDAMEDClass III (EU MDR)
Ref BP-0002-011Model BP2502-10 (EUROPE-FIAB)
Identity
- Trade Name
- Bioptimal Bipolar Pacing Catheter EUDAMED
- Device Name
- Bipolar Pacing Catheter EUDAMED
- Model / Reference
- BP2502-10 (EUROPE-FIAB) EUDAMEDBP-0002-011 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08886483507135 EUDAMED
- Basic UDI-DI
- B-08886483507135 EUDAMED
- EMDN Code
- C020201 TEMPORARY ENDOCARDIAL LEADS EUDAMED
Classification
- Device Class
- Class III EUDAMED
- Market of Registration
- Germany EUDAMED
Clinical & Handling
Sterile
Yes
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
Yes
EUDAMED
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 — MDD — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-08886483507135 | 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 (1)
- EUDAMED d1897e99-eb23-4677-8436-149faaf203f4 61 fields · synced Jun 18, 2026