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ViewSite Brain Access System (VBAS) TC171105AC - EUDAMED Registration 00859261006210

Access comprehensive regulatory information for ViewSite Brain Access System (VBAS) TC171105AC in the European Union medical device market through Pure Global AI's free database. This Class III device is registered with EU EUDAMED under Primary DI 00859261006210 and manufactured by Vycor Medical Inc. in United States.

This page provides complete registration details including trade name (ViewSite Brain Access System), manufacturer information, authorized representative details, competent authority (Agence Nationale de Sรฉcuritรฉ du Mรฉdicament et des Produits de Santรฉ), 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 III
00859261006210
No
ViewSite Brain Access System (VBAS) TC171105AC
Trade Name: ViewSite Brain Access System
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Device Description (EMDN)

MINIMALLY INVASIVE SURGERY SPREADERS AND RETRACTORS, SINGLE-USE

Device Classification
Risk Class
Class III
CND Nomenclatures Code
K01020106
Trade Name
ViewSite Brain Access System
Implantable
No
Reusable
No
Measuring Function
No
Registration Information
Primary DI
00859261006210
Basic UDI
B-00859261006210
Version Date
September 04, 2024
Manufacturer Last Update
February 29, 2024
Active Status
No
Manufacturer
Manufacturer Name
Vycor Medical Inc.
Country
United States
Country Type
NON_EU
Address
951 BROKEN SOUND PARKWAY BOCA RATON,
Email
aliddell@vycormedical.com
Authorized Representative
SRN
FR-AR-000000182
Country
France
Address
11 RUE EMILE ZOLA BP 2332 GRENOBLE cedex 2
Email
info@medimark-europe.com
Telephone
+33 4 76 86 43 22
Regulatory Information
Competent Authority
Agence Nationale de Sรฉcuritรฉ du Mรฉdicament et des Produits de Santรฉ
Applicable Legislation
MDD (Directive 93/42/EEC on Medical Devices)
Placed On The Market
Sweden
Market Available
Austria:2023-01-02~None, Belgium:2023-01-02~None, Cyprus:2023-01-02~None, Denmark:2023-01-02~None, Finland:2023-01-02~None, France:2023-01-02~None, Germany:2023-01-02~None, Greece:2023-01-02~None, Ireland:2023-01-02~None, Italy:2023-01-02~None, Netherlands:2023-01-02~None, Norway:2023-01-02~None, Poland:2023-01-02~None, Portugal:2023-01-02~None, Spain:2023-01-02~None, Sweden:2023-01-02~None, United Kingdom (Northern Ireland only):2023-01-02~None
Device Characteristics
Human Tissues
No
Animal Tissues
No