Identity
- Trade Name
- SAADAT EUDAMED
- Device Name
- Electrocardiograph EUDAMED
- Model / Reference
- Dena 1210 EUDAMED99113285 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06261388700539 EUDAMED
- Basic UDI-DI
- 62613887Dena1210MP EUDAMED
- EMDN Code
- Z12050301 GENERAL PURPOSE ELECTROCARDIOGRAPHS EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Sweden 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
Saadat by Pooyandegan rah saadat — Class IIa — 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 | 62613887Dena1210MP | Class IIa | Active |
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Manufacturer
- Manufacturer
- Pooyandegan rah saadat
- EUDAMED SRN
- IR-MF-000007104
- Authorised Representative
- Trionara Technologies AB SE-AR-000005045
Sources (1)
- EUDAMED d435c9ab-7637-45f3-bf7d-59cee3cc735a 61 fields · synced Jun 19, 2026