Identity
- Trade Name
- Ingenuity CT System Upgrade EUDAMEDFDA UDI
- Generic Name
- Full-body CT system FDA UDI
- Device Name
- Ingenuity CT System EUDAMED
- Model / Reference
- 728327 EUDAMEDIngenuity CT System Upgrade FDA UDI
Identifiers
- Catalog Number
- 728327 FDA UDI
- Primary DI / UDI-DI
- 00884838098701 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 System Upgrade 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 aabfaf6b-e07b-406d-b931-21aff77006e6 61 fields · synced Oct 6, 2026
- FDA UDI 86c13d62-adc6-4f05-a292-c3fe36e32edc 33 fields · synced May 30, 2026