Identity
- Trade Name
- HiRise EUDAMEDFDA UDI
- Generic Name
- Limited-view-field CT system FDA UDI
- Device Name
- HiRise EUDAMEDCBCT upper & lower extremities including the pelvis FDA UDI
- Model / Reference
- 1040 EUDAMED1040-230 FDA UDI
- Description
- CBCT upper & lower extremities including the pelvis FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00860004550037 EUDAMEDFDA UDI
- Basic UDI-DI
- 8631520003CBCTDevicesCL EUDAMED
- Direct Marketing DI
- 00860004550037 EUDAMED
- 510(k) Number
- K203187 FDA UDI
- FDA Product Code
- JAK FDA UDI
- EMDN Code
- Z11030699 COMPUTED TOMOGRAPHS (CT) - OTHER EUDAMED
- GMDN Term
- Limited-view-field CT system FDA UDI
Classification
- Device Class
- Class IIb EUDAMEDClass II FDA UDI
- Regulation Number
- 892.1750 FDA UDI
- Market of Registration
- Germany 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
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
Yes
FDA UDI
HiRise by CurveBeam LLC — Class IIb — FDA_510K, MDR — listed in EUDAMED, FDA GUDID, FDA 510(k) — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
United States Active
FDA_510K
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K203187 | Class IIb | Active |
| EUDAMED | European Union | CE/MDR | 8631520003CBCTDevicesCL | Class IIb | Active |
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Manufacturer
- Manufacturer
- CurveBeam LLC
- EUDAMED SRN
- US-MF-000004033
- Authorised Representative
- ea-services FR-AR-000003449
Sources (3)
- EUDAMED 37ff4c6d-8930-4b17-8e07-dfc5227b9dc7 61 fields · synced Jul 21, 2026
- FDA UDI 6b2dc9c9-8623-435a-9e65-fcd6623c3a30 34 fields · synced May 30, 2026
- FDA 510(k) K203187 1 fields · synced May 18, 2026