EPCORSA 15 / Astro 15
- Risk class
- Class IIb
- CND nomenclatures code
- Z11069005
- Trade name
- EPSILON HEALTHCARE SOLUTIONS PRIVATE LIMITED
- Implantable
- No
- Reusable
- No
- Measuring function
- No
- Primary DI
- 08906172310027
- Basic UDI
- 890617231XRM1M3
- Version date
- February 13, 2025
- Manufacturer last update
- April 13, 2023
- Active status
- Yes
- Manufacturer name
- EPSILON HEALTHCARE SOLUTIONS PRIVATE LIMITED
- Country
- India
- Country type
- NON_EU
- Address
- RIICO INDUSTRIAL AREA P.NO. G-1-57 303007 JAIPUR
- ssr@epsilonhealthcare.com
- Name
- mdi Europa GmbH
- SRN
- DE-AR-000006218
- Country
- Germany
- Address
- 71 Langenhagener Straße Langenhagen
- info@mdi-europa.com
- 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
- Human tissues
- No
- Animal tissues
- No
DIAGNOSTIC IMAGING WORKSTATIONS
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.