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D-Spect Cardio
EUDAMEDFDA UDIClass IIa (EU MDR)
Ref 8010121-01Model Model 004 (CARDIO) / Model 002 (VISTA)
Identity
- Trade Name
- D-SPECT CARDIO EUDAMEDD-SPECT® Cardio FDA UDI
- Generic Name
- SPECT system, annular detector array FDA UDI
- Device Name
- D-SPECT EUDAMEDSingle Photon Emission Computed Tomography system, 230V FDA UDI
- Model / Reference
- Model 004 (CARDIO) / Model 002 (VISTA) EUDAMED8010121-01 EUDAMED004 FDA UDI
- Description
- Single Photon Emission Computed Tomography system, 230V FDA UDI
Identifiers
- Catalog Number
- 8010121-01 FDA UDI
- Primary DI / UDI-DI
- 07290108670073 EUDAMEDFDA UDI
- Basic UDI-DI
- 729010867DSPECTFJ EUDAMED
- Direct Marketing DI
- 07290108670073 EUDAMED
- 510(k) Number
- K161740 FDA UDI
- FDA Product Code
- KPS FDA UDI
- EMDN Code
- Z11020104 FIXED STATION GAMMA CAMERAS WITH MULTIPLE HEADS - WITHOUT ‘TOTAL BODY’ ACQUISITION EUDAMED
- GMDN Term
- SPECT system, annular detector array FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA UDI
- Regulation Number
- 892.1200 FDA UDI
- Market of Registration
- Germany EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
No
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
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
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
D-Spect Cardio by Spectrum Dynamics Medical ltd — Class IIa — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 729010867DSPECTFJ | Class IIa | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | Pending data |
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Manufacturer
- Manufacturer
- Spectrum Dynamics Medical ltd
- EUDAMED SRN
- IL-MF-000013887
- Authorised Representative
- SPECTRUM DYNAMICS MEDICAL FRANCE SAS FR-AR-000013226
Sources (2)
- EUDAMED 27b2bdac-60c1-450f-a0be-cd74a605f043 61 fields · synced Jun 18, 2026
- FDA UDI cca9e6a6-61fb-4fc3-8d24-a80f35e477dc 35 fields · synced May 30, 2026