Identity
- Trade Name
- D-SPECT VISTA EUDAMED
- Device Name
- D-SPECT® CARDIO Cardiac Scanner System EUDAMED
- Model / Reference
- Model 004 EUDAMED8010267-01 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 07649991184097 EUDAMED
- Basic UDI-DI
- 7649991184D-SPECTYM EUDAMED
- Direct Marketing DI
- 07649991184097 EUDAMED
- EMDN Code
- Z11020104 FIXED STATION GAMMA CAMERAS WITH MULTIPLE HEADS - WITHOUT ‘TOTAL BODY’ ACQUISITION EUDAMED
Classification
- Device Class
- Class IIa 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
D-Spect Vista by Spectrum Dynamics Medical SA — 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 | 7649991184D-SPECTYM | Class IIa | Active |
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Manufacturer
- Manufacturer
- Spectrum Dynamics Medical SA
- EUDAMED SRN
- CH-MF-000032669
- Authorised Representative
- SPECTRUM DYNAMICS MEDICAL FRANCE SAS FR-AR-000013226
Sources (1)
- EUDAMED ddf1dff2-a8ec-429e-9daa-45a766bef4d5 61 fields · synced Oct 6, 2026