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Syntel® Silicone Over-the-Wire Embolectomy Catheter
EUDAMEDClass IIa (EU MDR)
Ref A4E06M
Identity
- Trade Name
- Syntel® Silicone Over-the-Wire Embolectomy Catheter EUDAMED
- Device Name
- Syntel® Silicone Over-the-Wire Embolectomy Catheter EUDAMED
- Model / Reference
- A4E06M EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00840663111886 EUDAMED
- Basic UDI-DI
- 08406631SyntelOTWQU 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
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Syntel® Silicone Over-the-Wire Embolectomy Catheter 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 | 08406631SyntelOTWQU | Class IIa | Active |
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Manufacturer
- Manufacturer
- LeMaitre Vascular, Inc.
- EUDAMED SRN
- US-MF-000016778
- Authorised Representative
- LeMaitre Vascular GmbH DE-AR-000013539
Sources (1)
- EUDAMED 7442b4a5-185e-4356-bb08-08d2075a78b8 61 fields · synced Jun 18, 2026