Identity
- Trade Name
- Ingenuity CT EUDAMEDFDA UDI
- Generic Name
- Full-body CT system FDA UDI
- Device Name
- Ingenuity CT System EUDAMED
- Model / Reference
- 728326 EUDAMEDIngenuity CT FDA UDI
Identifiers
- Catalog Number
- 728326 FDA UDI
- Primary DI / UDI-DI
- 00884838059511 EUDAMEDFDA UDI
- Basic UDI-DI
- 0884838BM279TB EUDAMED
- FDA Product Code
- JAK FDA UDI
- EMDN Code
- Z11030601 COMPUTED TOMOGRAPHS - NOT EXCEEDING 2 LAYERS EUDAMED
- GMDN Term
- Full-body CT system FDA UDI
Classification
- Device Class
- Class IIb EUDAMEDClass II FDA UDI
- Regulation Number
- 892.1750 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
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
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Ingenuity CT by Philips Medical Systems Nederland B.V. — 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 | 0884838BM279TB | Class IIb | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIb | Pending data |
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Manufacturer
- Manufacturer
- Philips Medical Systems Nederland B.V.
- EUDAMED SRN
- NL-MF-000001489
Sources (2)
- EUDAMED 5a81aa83-fa31-456d-a0ec-b1e4ed6e769a 61 fields · synced Oct 6, 2026
- FDA UDI 7a93a5ac-6ac4-4fd2-97ad-de8a2c649fd6 33 fields · synced May 30, 2026