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EPCORSA 15 / Astro 15 - EUDAMED Registration 08906172310027

Access comprehensive regulatory information for EPCORSA 15 / Astro 15 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 08906172310027 and manufactured by EPSILON HEALTHCARE SOLUTIONS PRIVATE LIMITED in India.

This page provides complete registration details including trade name (EPSILON HEALTHCARE SOLUTIONS PRIVATE LIMITED), manufacturer information, authorized representative details, competent authority (DE/CA09 - Staatliches Gewerbeaufsichtsamt Hannover), 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
08906172310027
Yes
EPCORSA 15 / Astro 15
Trade Name: EPSILON HEALTHCARE SOLUTIONS PRIVATE LIMITED
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Device Description (EMDN)

DIAGNOSTIC IMAGING WORKSTATIONS

Device Classification
Risk Class
Class IIb
CND Nomenclatures Code
Z11069005
Trade Name
EPSILON HEALTHCARE SOLUTIONS PRIVATE LIMITED
Implantable
No
Reusable
No
Measuring Function
No
Registration Information
Primary DI
08906172310027
Basic UDI
890617231XRM1M3
Version Date
February 13, 2025
Manufacturer Last Update
April 13, 2023
Active Status
Yes
Manufacturer
Country
India
Country Type
NON_EU
Address
RIICO INDUSTRIAL AREA P.NO. G-1-57 303007 JAIPUR
Email
ssr@epsilonhealthcare.com
Authorized Representative
SRN
DE-AR-000006218
Country
Germany
Address
71 Langenhagener StraรŸe Langenhagen
Email
info@mdi-europa.com
Regulatory Information
Competent Authority
DE/CA09 - Staatliches Gewerbeaufsichtsamt Hannover
Applicable Legislation
MDR (REGULATION (EU) 2017/745 on medical devices)
Placed On The Market
Belgium
Market Available
Belgium:2025-02-01~2099-12-31
Device Characteristics
Human Tissues
No
Animal Tissues
No