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Bioptimal Embolectomy Catheter
EUDAMEDClass IIa (EU MDR)
Ref 23-000006-18Model EL1580 Ref EL3281Model EL3280 (Medline)Ref EL3341Model EL3340 (Medline)Ref 23-000006-16Model EL1480 Ref EL1781Model EL1780 (Medline)Ref EL1581Model EL1580 (Medline)Ref EL3261Model EL3260 (Medline)
Identity
- Trade Name
- Bioptimal Embolectomy Catheter EUDAMED
- Device Name
- Embolectomy Catheter EUDAMED
- Model / Reference
- EL1580 EUDAMED23-000006-18 EUDAMEDEL3280 (Medline) EUDAMEDEL3281 EUDAMEDEL3340 (Medline) EUDAMEDEL3341 EUDAMEDEL1480 EUDAMED23-000006-16 EUDAMEDEL1780 (Medline) EUDAMEDEL1781 EUDAMEDEL1580 (Medline) EUDAMEDEL1581 EUDAMEDEL3260 (Medline) EUDAMEDEL3261 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08886483504486 EUDAMED08886483538863 EUDAMED08886483538849 EUDAMED08886483504462 EUDAMED08886483538825 EUDAMED08886483538818 EUDAMED08886483538870 EUDAMED
- Basic UDI-DI
- B-08886483504486 EUDAMEDB-08886483538863 EUDAMEDB-08886483538849 EUDAMEDB-08886483504462 EUDAMEDB-08886483538825 EUDAMEDB-08886483538818 EUDAMEDB-08886483538870 EUDAMED
- EMDN Code
- C019002 EMBOLECTOMY CATHETERS EUDAMED
Classification
- Device Class
- Class IIa 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 Embolectomy Catheter by Bioptimal International Pte. Ltd. — Class IIa — 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-08886483504486 | Class IIa | 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 (7)
- EUDAMED 3871312e-0937-4bfd-9787-beaff9d7c13b 61 fields · synced Sep 17, 2026
- EUDAMED 10dbeb0d-4066-47db-b71a-d9aed2b29f5b 61 fields · synced May 17, 2026
- EUDAMED fc680ceb-7d67-4df3-bb76-cca084d0ad98 61 fields · synced May 17, 2026
- EUDAMED d1d2b948-efc4-4aed-8d63-0fa1c9b1d1b2 61 fields · synced May 17, 2026
- EUDAMED 66d57845-749e-46c9-af8e-dd04989fa355 61 fields · synced May 18, 2026
- EUDAMED 9750b602-6a2e-45db-9c92-9cd3bd796e39 61 fields · synced May 18, 2026
- EUDAMED 61e89159-618b-40a7-8429-720260cf9c98 61 fields · synced May 19, 2026