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Tack Endovascular System (4F) - EUDAMED Registration 00863328000141

Access comprehensive regulatory information for Tack Endovascular System (4F) in the European Union medical device market through Pure Global AI's free database. This Class IIb device is registered with EU EUDAMED under Primary DI 00863328000141 and manufactured by Intact Vascular, Inc. in United States.

This page provides complete registration details including trade name (Tack Endovascular System (4F, 1.5-4.5mm)), manufacturer information, authorized representative details, competent authority (State Agency of Medicines, Department of Medical Devices), and regulatory compliance data from the official EU EUDAMED medical device database. Pure Global AI offers free access to the European Union's complete medical device registry, helping global MedTech companies navigate EU MDR regulations efficiently.

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EUDAMED Official Data
Class IIb
00863328000141
No
Tack Endovascular System (4F)
Trade Name: Tack Endovascular System (4F, 1.5-4.5mm)
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Device Description (EMDN)

NON-STAINLESS STEEL PERIPHERAL VASCULAR BARE METAL STENTS

Device Classification
Risk Class
Class IIb
CND Nomenclatures Code
P070402020102
Trade Name
Tack Endovascular System (4F, 1.5-4.5mm)
Implantable
Yes
Reusable
No
Measuring Function
No
Registration Information
Primary DI
00863328000141
Basic UDI
B-00863328000141
Version Date
March 05, 2025
Manufacturer Last Update
March 04, 2025
Active Status
No
Manufacturer
Manufacturer Name
Intact Vascular, Inc.
Country
United States
Country Type
NON_EU
Address
5905 Nathan Lane North Plymouth
Email
eudamed@philips.com
Authorized Representative
SRN
EE-AR-000004308
Country
Estonia
Address
30 Laki tn Tallinn
Email
enquiries@qualityfirstint.com
Telephone
+3726104196
Regulatory Information
Competent Authority
State Agency of Medicines, Department of Medical Devices
Applicable Legislation
MDD (Directive 93/42/EEC on Medical Devices)
Placed On The Market
Netherlands
Market Available
Austria:2012-03-30~None, Belgium:2012-03-30~None, Bulgaria:2012-03-30~None, Croatia:2012-03-30~None, Cyprus:2012-03-30~None, Czechia:2012-03-30~None, Denmark:2012-03-30~None, Estonia:2012-03-30~None, Finland:2012-03-30~None, France:2012-03-30~None, Germany:2012-03-30~None, Greece:2012-03-30~None, Hungary:2012-03-30~None, Iceland:2012-03-30~None, Ireland:2012-03-30~None, Italy:2012-03-30~None, Latvia:2012-03-30~None, Liechtenstein:2012-03-30~None, Lithuania:2012-03-30~None, Luxembourg:2012-03-30~None, Malta:2012-03-30~None, Netherlands:2012-03-30~None, Norway:2012-03-30~None, Poland:2012-03-30~None, Portugal:2012-03-30~None, Romania:2012-03-30~None, Slovakia:2012-03-30~None, Slovenia:2012-03-30~None, Spain:2012-03-30~None, Sweden:2012-03-30~None, Türkiye:2012-03-30~None, United Kingdom (Northern Ireland only):2012-03-30~None
Device Characteristics
Human Tissues
No
Animal Tissues
No