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Tack Endovascular System (4F, 1.5-4.5mm)
EUDAMEDClass IIb (EU MDR)
Ref 154090042Ref 154150042
Identity
- Trade Name
- Tack Endovascular System (4F, 1.5-4.5mm) EUDAMED
- Device Name
- Tack Endovascular System (4F) EUDAMED
- Model / Reference
- 154090042 EUDAMED154150042 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00863328000134 EUDAMED00863328000141 EUDAMED
- Basic UDI-DI
- B-00863328000134 EUDAMEDB-00863328000141 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 (4F, 1.5-4.5mm) 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-00863328000134 | 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 (2)
- EUDAMED 8f8921c5-3cfe-416d-80de-4ebc2cf4b448 61 fields · synced Sep 17, 2026
- EUDAMED 5e9f366b-d9ce-4167-99de-b589eec14c6c 61 fields · synced May 18, 2026