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Bioptimal Embolectomy Catheter
EUDAMEDClass IIa (EU MDR)
Ref EL1441Model EL1440 (Medline)
Identity
- Trade Name
- Bioptimal Embolectomy Catheter EUDAMED
- Device Name
- Embolectomy Catheter EUDAMED
- Model / Reference
- EL1440 (Medline) EUDAMEDEL1441 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08886483538795 EUDAMED
- Basic UDI-DI
- B-08886483538795 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-08886483538795 | 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 (1)
- EUDAMED 39a1aa4a-3189-492b-99b0-0b8dd83019b1 61 fields · synced May 29, 2026