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TufTex® Embolectomy Catheter
EUDAMEDClass IIa (EU MDR)
Ref 1601-26MRef 1601-68MRef 1601-58MRef 1601-28MRef 1601-24MRef 1601-38MRef 1601-34MRef 1601-78M
Identity
- Trade Name
- TufTex® Embolectomy Catheter EUDAMED
- Device Name
- TufTex Embolectomy Catheter EUDAMED
- Model / Reference
- 1601-26M EUDAMED1601-68M EUDAMED1601-58M EUDAMED1601-28M EUDAMED1601-24M EUDAMED1601-38M EUDAMED1601-34M EUDAMED1601-78M EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00840663111206 EUDAMED00840663111282 EUDAMED00840663111275 EUDAMED00840663111213 EUDAMED00840663111190 EUDAMED00840663111237 EUDAMED00840663111220 EUDAMED00840663111299 EUDAMED
- Basic UDI-DI
- 08406631TufTexSLE8 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
EUDAMEDEUDAMED
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® 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 | 08406631TufTexSLE8 | 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 (8)
- EUDAMED 9b698c01-b338-4362-912d-cff75a1b3c54 61 fields · synced Aug 3, 2026
- EUDAMED 42288ccb-454f-4b24-b835-d2f57c2ccace 61 fields · synced May 16, 2026
- EUDAMED c3f6395d-ea39-4f9a-bf74-924907449c2d 61 fields · synced May 17, 2026
- EUDAMED a1d8cf7b-6667-4c36-b27b-eacbdb1bc234 61 fields · synced May 17, 2026
- EUDAMED 8c712f29-5acd-45a3-8bca-f8da8dcaaae4 61 fields · synced May 18, 2026
- EUDAMED a8787574-4aaa-4820-827f-7e112cf8d0c3 61 fields · synced May 18, 2026
- EUDAMED eea3f040-c430-42fd-8805-a288ca9431bd 61 fields · synced May 18, 2026
- EUDAMED 515419ea-bc2b-489b-9ca9-f7bba3914cc9 61 fields · synced May 19, 2026