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The AIO Solution® (All-in-One Patient Positioning Solution)
EUDAMEDFDA UDIClass I (EU MDR)
Ref 38001Model 0030
Identity
- Trade Name
- The AIO Solution® (All-in-One Patient Positioning Solution) EUDAMEDOrfit Industries FDA UDI
- Generic Name
- Radiological whole-body positioner FDA UDI
- Device Name
- The AIO Solution® (All-in-One Patient Positioning Solution) EUDAMEDAIO 3.0 - Base plate CFL FDA UDI
- Model / Reference
- 0030 EUDAMED38001 EUDAMEDFDA UDI
- Description
- AIO 3.0 - Base plate CFL FDA UDI
Identifiers
- Primary DI / UDI-DI
- 05420028702833 EUDAMEDFDA UDI
- Basic UDI-DI
- 5420028700304T EUDAMED
- Direct Marketing DI
- 05420028702833 EUDAMED
- FDA Product Code
- IYE FDA UDI
- EMDN Code
- Z11010980 MAGNETIC RESONANCE RADIOTHERAPY INSTRUMENTS - HARDWARE ACCESSORIES EUDAMED
- GMDN Term
- Radiological whole-body positioner FDA UDI
Classification
- Device Class
- Class I EUDAMEDClass II FDA UDI
- Regulation Number
- 892.5050 FDA UDI
- Market of Registration
- Belgium 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
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
MR Conditional FDA UDI
The AIO Solution® (All-in-One Patient Positioning Solution) by Orfit Industries — Class I — MDR, FDA UDI — listed in EUDAMED, FDA GUDID
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 | 5420028700304T | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Orfit Industries
- EUDAMED SRN
- BE-MF-000007872
Sources (2)
- EUDAMED 1e574739-58b3-4283-ab44-02b75c227f52 61 fields · synced Jun 18, 2026
- FDA UDI 9ff25fb8-8197-4bcf-9049-25cf9a0901ea 34 fields · synced May 30, 2026