Identity
- Trade Name
- Catphan® FDA UDI
- Generic Name
- CT phantom, test object FDA UDI
- Device Name
- CTP764 EUDAMEDHigh Resolution Module FDA UDI
- Model / Reference
- CTP764 EUDAMEDFDA UDI
- Description
- High Resolution Module FDA UDI
Identifiers
- Catalog Number
- CTP764 FDA UDI
- Primary DI / UDI-DI
- 00812266031403 EUDAMEDFDA UDI
- Basic UDI-DI
- 081226603CTP764XE 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
Ctp764 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 | 081226603CTP764XE | 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 dde92c3a-d05d-4b99-b7fd-577d2979ae48 61 fields · synced Jun 20, 2026
- FDA UDI 4d828122-5771-4980-8238-49d66f5fb278 34 fields · synced May 30, 2026