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Syntel® Silicone Over-the-Wire Embolectomy Catheter

EUDAMED

Class IIa (EU MDR)

Ref A4E08MRef A4E02MRef A4E01MRef A4E05M

by LeMaitre Vascular, Inc.

Identity

Trade Name
Syntel® Silicone Over-the-Wire Embolectomy Catheter EUDAMED
Device Name
Syntel® Silicone Over-the-Wire Embolectomy Catheter EUDAMED
Model / Reference
A4E08M EUDAMED
A4E02M EUDAMED
A4E01M EUDAMED
A4E05M EUDAMED

Identifiers

Primary DI / UDI-DI
00840663111893 EUDAMED
00840663111848 EUDAMED
00840663111831 EUDAMED
00840663111879 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

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Manufacturer

Manufacturer
LeMaitre Vascular, Inc.
EUDAMED SRN
US-MF-000016778
Authorised Representative
LeMaitre Vascular GmbH DE-AR-000013539

Sources (4)

  • EUDAMED a73427f4-5965-49d7-a9bb-e08964124d93 61 fields · synced Jul 17, 2026
  • EUDAMED 17f347ce-3230-4659-83d3-5bdf07af2bfd 61 fields · synced May 11, 2026
  • EUDAMED df2eba02-6f3d-4fd1-b5e0-d344d58625b3 61 fields · synced May 18, 2026
  • EUDAMED 1a95d010-b334-40ab-aa1e-0cbe04b283a3 61 fields · synced May 19, 2026