← Back to catalogue
Syntel® Silicone Embolectomy Catheter - Regular Tip
EUDAMEDClass IIa (EU MDR)
Ref 1801-78MRef 1801-48MRef 1801-54MRef 1801-68MRef 1801-58M
Identity
- Trade Name
- Syntel® Silicone Embolectomy Catheter - Regular Tip EUDAMED
- Device Name
- Syntel® Silicone Embolectomy Catheter - Regular Tip EUDAMED
- Model / Reference
- 1801-78M EUDAMED1801-48M EUDAMED1801-54M EUDAMED1801-68M EUDAMED1801-58M EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00840663111824 EUDAMED00840663111787 EUDAMED00840663111794 EUDAMED00840663111817 EUDAMED00840663111800 EUDAMED
- Basic UDI-DI
- 08406631SyntelRTST 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
No
EUDAMED
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
Yes
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Syntel® Silicone Embolectomy Catheter - Regular Tip by LeMaitre Vascular, Inc. — Class IIa — MDR — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 08406631SyntelRTST | Class IIa | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- LeMaitre Vascular, Inc.
- EUDAMED SRN
- US-MF-000016778
- Authorised Representative
- LeMaitre Vascular GmbH DE-AR-000013539
Sources (5)
- EUDAMED 6538b4bd-f46e-44ab-aec6-27ceb7ff7aef 61 fields · synced Jul 31, 2026
- EUDAMED 9d793f21-6161-4efe-8075-8395d276ec9c 61 fields · synced May 18, 2026
- EUDAMED 4fea5855-82c0-4629-b96d-646aeee263bc 61 fields · synced May 18, 2026
- EUDAMED 3a99db9a-9e68-4c98-8e8d-8307c22d35a0 61 fields · synced May 18, 2026
- EUDAMED 612a6342-97c4-49a4-a4f4-ec96f36c00fa 61 fields · synced May 18, 2026