Identity
- Trade Name
- TruPlan EUDAMEDFDA UDI
- Generic Name
- CT system application software FDA UDI
- Device Name
- TruPlan EUDAMED
- Model / Reference
- v3.x EUDAMEDTruPlan v2.1 EUDAMED2.1 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00882916000523 EUDAMEDFDA UDI
- Basic UDI-DI
- 882916TRP68 EUDAMED
- Direct Marketing DI
- 00882916000523 EUDAMED
- 510(k) Number
- K202212 FDA UDI
- FDA Product Code
- LLZ FDA UDI
- EMDN Code
- Z11030682 COMPUTED TOMOGRAPHS (CT) - SOFTWARE ACCESSORIES EUDAMED
- GMDN Term
- CT system application software FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA UDI
- Regulation Number
- 892.2050 FDA UDI
- Special Device Type
- Software EUDAMED
- Market of Registration
- Spain 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
Yes
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
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
TruPlan by Circle Cardiovascular Imaging Inc — 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 | 882916TRP68 | Class IIa | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Circle Cardiovascular Imaging Inc
- EUDAMED SRN
- CA-MF-000011835
- Authorised Representative
- QDossier B.V. NL-AR-000033747
Sources (2)
- EUDAMED 8ab4e11a-c2a2-4b6f-984a-9e8afcd130a2 61 fields · synced Jun 9, 2026
- FDA UDI 73b72683-0eb9-46b5-ac5d-11c0f2a7704d 33 fields · synced May 27, 2026