Identity
- Trade Name
- VERITON CT 216 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 EUDAMED8010172-01 EUDAMEDVERITON CT 16 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
- 8010172-01 FDA UDI
- Primary DI / UDI-DI
- 07290108670127 EUDAMEDFDA UDI
- Basic UDI-DI
- 729010867VERITONCT22 EUDAMED
- Direct Marketing DI
- 07290108670127 EUDAMED
- 510(k) Number
- K190457 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
- France 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 216 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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Spectrum Dynamics Medical ltd
- EUDAMED SRN
- IL-MF-000013887
- Authorised Representative
- SPECTRUM DYNAMICS MEDICAL FRANCE SAS FR-AR-000013226
Sources (2)
- EUDAMED 26329783-5995-44cd-9791-105fcd494477 61 fields · synced Jun 18, 2026
- FDA UDI dd641007-d07f-44c5-bee9-095515bc7db1 35 fields · synced May 30, 2026