Identity
- Trade Name
- RADGIL2 FDA UDI
- Generic Name
- In vitro ionizing-radiation blood irradiator FDA UDI
- Device Name
- x rays blood irradiator FDA UDI
- Model / Reference
- RADGIL2 US FDA UDI
- Description
- x rays blood irradiator FDA UDI
Identifiers
- Catalog Number
- 03360004 FDA UDI
- Primary DI / UDI-DI
- B850033600040 FDA UDI
- 510(k) Number
- K201177 FDA UDI
- FDA Product Code
- MOT FDA UDI
- GMDN Term
- In vitro ionizing-radiation blood irradiator FDA UDI
Classification
- Device Class
- U FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
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
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: In vitro ionizing-radiation blood irradiator
Radgil2 by Gilardoni Spa — Class U — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as In vitro ionizing-radiation blood irradiator.
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Unknown
MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class U | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class U | Pending data |
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Manufacturer
- Manufacturer
- Gilardoni Spa
Sources (2)
- FDA UDI 8b947063-5b53-4a71-8013-4fdb91d65a85 37 fields · synced Jun 18, 2026
- EUDAMED 1 fields · synced Jun 3, 2026