Identity
- Trade Name
- VERITON CT 364 EUDAMEDVERITON CT FDA UDI
- Generic Name
- SPECT/CT system FDA UDI
- Device Name
- VERITON CT EUDAMEDSingle Photon Emission Computed Tomography System combined with a Computed Tomography (CT) system for x-ray imaging. FDA UDI
- Model / Reference
- VERITON CT EUDAMED8010420-01 EUDAMEDVERITON CT 364 FDA UDI
- Description
- Single Photon Emission Computed Tomography System combined with a Computed Tomography (CT) system for x-ray imaging. FDA UDI
Identifiers
- Catalog Number
- 8010420-01 FDA UDI
- Primary DI / UDI-DI
- 07290108670219 EUDAMEDFDA UDI07649991184042 EUDAMED
- Basic UDI-DI
- 729010867VERITONCT22 EUDAMED7649991184VERITON-CTRN EUDAMED
- Direct Marketing DI
- 07290108670219 EUDAMED07649991184042 EUDAMED
- 510(k) Number
- K230600 FDA UDI
- FDA Product Code
- KPS FDA UDIJAK FDA UDI
- EMDN Code
- Z11020201 CT/GAMMA CAMERA SYSTEMS EUDAMED
- GMDN Term
- SPECT/CT system FDA UDI
Classification
- Device Class
- Class IIb EUDAMEDClass II FDA UDI
- Regulation Number
- 892.1200 FDA UDI892.1750 FDA UDI
- Market of Registration
- Poland 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
Veriton Ct 364 by Spectrum Dynamics Medical ltd — Class IIb — 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 | 729010867VERITONCT22 | Class IIb | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIb | 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 (3)
- EUDAMED 04db35c2-2749-4f0e-adea-4d637af08a41 61 fields · synced Jul 12, 2026
- FDA UDI e80303d9-34a9-415d-a3ca-833d2f41f744 35 fields · synced May 30, 2026
- EUDAMED ce0ae08e-20b0-4172-bb0c-85b6a7a6a34e 61 fields · synced Jul 12, 2026