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Tack Endovascular System (6F, 4.0-8.0mm)
EUDAMEDClass IIb (EU MDR)
Ref 206135062Ref 206120062Ref 156135062
Identity
- Trade Name
- Tack Endovascular System (6F, 4.0-8.0mm) EUDAMEDTack Endovascular System EUDAMED
- Device Name
- Tack Endovascular System (6F) EUDAMED
- Model / Reference
- 206135062 EUDAMED206120062 EUDAMED156135062 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00850003494005 EUDAMED00850003494012 EUDAMED00863328000172 EUDAMED
- Basic UDI-DI
- B-00850003494005 EUDAMEDB-00850003494012 EUDAMEDB-00863328000172 EUDAMED
- EMDN Code
- P070402020102 NON-STAINLESS STEEL PERIPHERAL VASCULAR BARE METAL STENTS EUDAMED
Classification
- Device Class
- Class IIb EUDAMED
- Market of Registration
- Netherlands EUDAMED
Clinical & Handling
Sterile
Yes
EUDAMED
Implantable
Yes
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Tack Endovascular System (6F, 4.0-8.0mm) by Intact Vascular, Inc. — Class IIb — MDD — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-00850003494005 | Class IIb | Active |
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Manufacturer
- Manufacturer
- Intact Vascular, Inc.
- EUDAMED SRN
- US-MF-000011102
- Authorised Representative
- Quality First International OÜ EE-AR-000004308
Sources (3)
- EUDAMED 41f2f1c0-9d7c-4509-9c59-39e58fc2dcae 61 fields · synced Aug 1, 2026
- EUDAMED 671004d3-e59f-4d9d-bee4-ba05af0fe87a 61 fields · synced May 18, 2026
- EUDAMED 7d7265ad-8836-4b2f-b5bd-5644d15789e3 61 fields · synced Aug 1, 2026