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Epsilon Healthcare Solutions Private Limited
EUDAMEDClass IIb (EU MDR)
Ref EPCORSA 40 / Astro 40
Identity
- Trade Name
- EPSILON HEALTHCARE SOLUTIONS PRIVATE LIMITED EUDAMED
- Device Name
- EPCORSA 15 / Astro 15 EUDAMED
- Model / Reference
- EPCORSA 40 / Astro 40 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08906172310034 EUDAMED
- Basic UDI-DI
- 890617231XRM1M3 EUDAMED
- Direct Marketing DI
- 08906172310034 EUDAMED
- EMDN Code
- Z11069005 DIAGNOSTIC IMAGING WORKSTATIONS EUDAMED
Classification
- Device Class
- Class IIb EUDAMED
- Market of Registration
- Belgium EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Category: Tissue specimen x-ray system IVD
Epsilon Healthcare Solutions Private Limited by Epsilon Healthcare Solutions Private Limited — Class IIb — MDR — listed in EUDAMED
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Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 890617231XRM1M3 | Class IIb | Active |
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Manufacturer
- Manufacturer
- Epsilon Healthcare Solutions Private Limited
- EUDAMED SRN
- IN-MF-000034860
- Authorised Representative
- mdi Europa GmbH DE-AR-000006218
Sources (1)
- EUDAMED 538ad5b0-c060-49df-b632-f0eaeb2b2c0e 61 fields · synced Jun 19, 2026