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Invenia ABUS - EUDAMED Registration 00195278756237

Access comprehensive regulatory information for Invenia ABUS in the European Union medical device market through Pure Global AI's free database. This Class IIa device is registered with EU EUDAMED under Primary DI 00195278756237 and manufactured by GE Medical Systems Ultrasound and Primary Care Diagnostics, LLC in United States.

This page provides complete registration details including trade name (Invenia ABUS Premium), 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 IIa
00195278756237
Yes
Invenia ABUS
Trade Name: Invenia ABUS Premium
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Device Description (EMDN)

INTERNAL ULTRASOUND SCANNERS

Device Classification
Risk Class
Class IIa
CND Nomenclatures Code
Z11040101
Trade Name
Invenia ABUS Premium
Implantable
No
Reusable
No
Measuring Function
Yes
Registration Information
Primary DI
00195278756237
Basic UDI
8406821BUG00408HG
Active Status
Yes
Manufacturer
Country
United States
Country Type
NON_EU
Address
3200 N Grandview Blvd. Waukesha
Email
bryan.behn@gehealthcare.com
Authorized Representative
SRN
FR-AR-000000344
Country
France
Address
283 Rue de la Miniere BUC
Email
CoE.Postmarket@ge.com
Regulatory Information
Competent Authority
Agence Nationale de Sรฉcuritรฉ du Mรฉdicament et des Produits de Santรฉ
Applicable Legislation
MDR (REGULATION (EU) 2017/745 on medical devices)
Placed On The Market
France
Market Available
France:2024-10-17~2027-12-31
Device Characteristics
Human Tissues
No
Animal Tissues
No