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TufTex® Over-the-Wire Embolectomy Catheter
EUDAMEDClass IIa (EU MDR)
Ref 1651-54MRef 1651-48MRef 1651-44MRef 1651-74MRef 1651-68MRef 1651-58MRef 1651-88MRef 1651-84MRef 1651-78M
Identity
- Trade Name
- TufTex® Over-the-Wire Embolectomy Catheter EUDAMED
- Device Name
- TufTex® Over-the-Wire Embolectomy Catheter EUDAMED
- Model / Reference
- 1651-54M EUDAMED1651-48M EUDAMED1651-44M EUDAMED1651-74M EUDAMED1651-68M EUDAMED1651-58M EUDAMED1651-88M EUDAMED1651-84M EUDAMED1651-78M EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00840663112104 EUDAMED00840663112098 EUDAMED00840663112081 EUDAMED00840663112142 EUDAMED00840663112135 EUDAMED00840663112111 EUDAMED00840663112173 EUDAMED00840663112166 EUDAMED00840663112159 EUDAMED
- Basic UDI-DI
- 08406631TufTexOTWAL 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
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
TufTex® 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 | 08406631TufTexOTWAL | 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 (9)
- EUDAMED d4c5477c-d47e-436a-b317-4dff19d318df 61 fields · synced Aug 4, 2026
- EUDAMED 330a6a95-21ca-463c-8f25-7f740ca806c9 61 fields · synced May 16, 2026
- EUDAMED 67fae65a-309f-4fbc-b58c-91ef63c3a87f 61 fields · synced May 16, 2026
- EUDAMED a9bd35eb-1112-4f23-93bd-29d556ee2cb2 61 fields · synced May 16, 2026
- EUDAMED c9499bf7-acdf-4f09-802f-a9b0b0e60662 61 fields · synced May 17, 2026
- EUDAMED f79a08bb-578e-42e5-b9a3-13ed8d6cb2e4 61 fields · synced May 17, 2026
- EUDAMED 9426b3d3-b8aa-4601-a5c2-5c5684052f1c 61 fields · synced May 18, 2026
- EUDAMED 4df6423d-18ba-4cfd-99c2-07add86622f8 61 fields · synced May 18, 2026
- EUDAMED 5ffc8d08-d9e7-4789-8297-ce0ab9404169 61 fields · synced May 19, 2026