Identity
- Trade Name
- Medsynapse RIS-PACS EUDAMED
- Device Name
- Medsynapse EUDAMED
- Model / Reference
- 7.0 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 09898987000004 EUDAMED
- Basic UDI-DI
- 0989898700000FL EUDAMED
- Direct Marketing DI
- 09898987000004 EUDAMED
- EMDN Code
- Z110603 PICTURE ARCHIVING AND COMMUNICATION SYSTEMS EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Ireland 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
Yes
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Medsynapse RIS-PACS by Medsynaptic Pvt Ltd — Class I — MDR — listed in EUDAMED — regulatory data on deviCERTS
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 | 0989898700000FL | Class I | Active |
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Manufacturer
- Manufacturer
- Medsynaptic Pvt Ltd
- EUDAMED SRN
- IN-MF-000051166
- Authorised Representative
- International Associates Auditing & Certification Limited IE-AR-000002248
Sources (1)
- EUDAMED 6a3d42f9-b61c-4c2f-8083-31466367caf3 61 fields · synced May 23, 2026