Identity
- Trade Name
- CardioDoc EUDAMED
- Device Name
- Medsynapse EUDAMED
- Model / Reference
- 7.0 EUDAMED6.0 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 09898988000003 EUDAMED
- Basic UDI-DI
- 0989898700000FL EUDAMED
- Direct Marketing DI
- 09898988000003 EUDAMED
- EMDN Code
- Z110603 PICTURE ARCHIVING AND COMMUNICATION SYSTEMS EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Austria 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
CardioDoc 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 377d1999-9498-41ef-b186-5380d51b3a8b 61 fields · synced Jul 9, 2026