Identity
- Trade Name
- Apollo EZ DRF EUDAMEDVilla Sistemi Medicali FDA UDI
- Generic Name
- Stationary general-purpose fluoroscopic x-ray system, digital FDA UDI
- Device Name
- Apollo EUDAMED
- Model / Reference
- 9784K55331 EUDAMEDApollo EZ DRF FDA UDI
Identifiers
- Primary DI / UDI-DI
- 08057737120312 EUDAMEDFDA UDI
- Basic UDI-DI
- 805773712FT2209C EUDAMED
- Direct Marketing DI
- 08057737120312 EUDAMED
- 510(k) Number
- K050190 FDA UDI
- FDA Product Code
- KPW FDA UDIIXL FDA UDIKXJ FDA UDI
- EMDN Code
- Z11030702 DIGITAL REMOTE CONTROL TABLES EUDAMED
- GMDN Term
- Stationary general-purpose fluoroscopic x-ray system, digital FDA UDI
Classification
- Device Class
- Class IIb EUDAMEDClass II FDA UDI
- Regulation Number
- 892.1610 FDA UDI892.1670 FDA UDI892.1980 FDA UDI
- Market of Registration
- Italy 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
No
FDA UDI
Apollo EZ DRF by Villa Sistemi Medicali S.p.a. — Class IIb — 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 | 805773712FT2209C | Class IIb | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIb | Pending data |
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Manufacturer
- Manufacturer
- Villa Sistemi Medicali S.p.A.
- EUDAMED SRN
- IT-MF-000016860
Sources (2)
- EUDAMED f46d0b5a-1e56-4f87-83fe-635dce3f2816 61 fields · synced Jun 19, 2026
- FDA UDI fb26c79a-568e-41e8-ab35-7527b801a0b4 33 fields · synced May 30, 2026