Identity
- Trade Name
- Catphan® EUDAMEDFDA UDI
- Generic Name
- CT phantom, test object FDA UDI
- Device Name
- CTP500 EUDAMEDCatphan® 500, Complete Catphan® including housing, case, and Smári Image Analysis Database Service. FDA UDI
- Model / Reference
- Catphan® EUDAMEDCTP500 EUDAMEDFDA UDI
- Description
- Catphan® 500, Complete Catphan® including housing, case, and Smári Image Analysis Database Service. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00812266030024 EUDAMEDFDA UDI
- Basic UDI-DI
- 081226603CTP500WA EUDAMED
- Direct Marketing DI
- 00812266030024 EUDAMED
- FDA Product Code
- IXF FDA UDI
- EMDN Code
- Z119080 VARIOUS BIOIMAGING AND RADIOTHERAPY INSTRUMENTS - HARDWARE ACCESSORIES EUDAMED
- GMDN Term
- CT phantom, test object FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 892.1940 FDA UDI
- Market of Registration
- Sweden 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
No
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
Yes
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Catphan® by Phantom Laboratory — Class I — 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 | 081226603CTP500WA | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Phantom Laboratory
- EUDAMED SRN
- US-MF-000027490
- Authorised Representative
- Hoff & Lowendahl AB SE-AR-000001888
Sources (2)
- EUDAMED fc08200b-b92b-41e7-8a2d-05b13f7bb159 61 fields · synced Jul 10, 2026
- FDA UDI 6b1f85ac-1096-40d7-9539-593637c5bfb6 33 fields · synced May 30, 2026