Identity
- Trade Name
- SAADAT EUDAMED
- Device Name
- Patient care monitoring system EUDAMED
- Model / Reference
- Alvand H18 EUDAMED97412354 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06261388700744 EUDAMED
- Basic UDI-DI
- 62613887AlvandH18A3 EUDAMED
- Direct Marketing DI
- 06261388700744 EUDAMED
- EMDN Code
- Z1203020201 MULTI–PARAMETER PATIENT BEDSIDE MONITORS EUDAMED
Classification
- Device Class
- Class IIb EUDAMED
- Market of Registration
- Germany 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 IIb — 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 | 62613887AlvandH18A3 | Class IIb | 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 405c6b30-d595-4558-bd2a-f4c6eea3eb19 61 fields · synced Jun 19, 2026