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EUDAMED registration 00859261006234No

ViewSite Brain Access System (VBAS) TC120807AC

Vycor Medical Inc.Class IIIEU EUDAMEDTrade name: ViewSite Brain Access System
VerifiedEUDAMED · official EU database
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
00859261006234
Basic UDI
B-00859261006234
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
Name
MEDIMARK EUROPE
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 Sécurité du Médicament et des Produits de Santé
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
Device description (EMDN)

MINIMALLY INVASIVE SURGERY SPREADERS AND RETRACTORS, SINGLE-USE

About this record

Access comprehensive regulatory information for ViewSite Brain Access System (VBAS) TC120807AC 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 00859261006234 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 Sécurité du Médicament et des Produits de Santé), 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.