Epsilon Healthcare Solutions Private Limited
by Epsilon Healthcare Solutions Private Limited 4 variants
Ref EPCORSA 50 / Astro 50
Active
CE MDR
Valid until
Not listed
FDA recalls
Not applicable
Documents
None linked in EUDAMED
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | Number890617231XRM1M3 08906172310041 | Date10 Feb 2025 | StatusActive |
Certificates
EUDAMED lists no certificate for this device's Basic UDI-DI.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
European Union — CE/MDR Active
Specification
- Device Name
- EPCORSA 15 / Astro 15
- Model / Reference
- EPCORSA 50 / Astro 50
- Primary DI / UDI-DI
- 08906172310041
- Basic UDI-DI
- 890617231XRM1M3
- Direct Marketing DI
- 08906172310041
- EMDN Code
- Z11069005 Diagnostic imaging workstations
- Device Class
- Class IIb
- EU market of registration
- Belgium
Manufacturer details
- EUDAMED SRN
- IN-MF-000034860
- Authorised representative
- mdi Europa GmbH DE-AR-000006218
Other devices from Epsilon Healthcare Solutions Private Limited
Properties
Other properties (13)
- Sterile: No
- Implantable: No
- Reusable: No
- Contains Latex: No
- Reprocessed: No
- CMR Substance: No
- Human-derived: No
- Human Tissues: No
- Animal Tissues: No
- Endocrine Disruptor: No
- Administering Medicine: No
- Measuring Function: No
- Incorporates Medicinal Product: No