Identity
- Trade Name
- sterEOS EUDAMEDFDA UDIsterEOS® FDA UDI
- Generic Name
- Basic diagnostic x-ray system application software FDA UDI
- Device Name
- sterEOS EUDAMEDsterEOS workstation FDA UDI
- Model / Reference
- sterEOS EUDAMEDWorkstation 1.8 FDA UDI1.10 FDA UDI
- Description
- sterEOS workstation FDA UDI
Identifiers
- Primary DI / UDI-DI
- 03663999000047 EUDAMEDFDA UDI03663999000153 EUDAMEDFDA UDI
- Basic UDI-DI
- 3663999RWS01A5 EUDAMED
- Direct Marketing DI
- 03663999000047 EUDAMED03663999000153 EUDAMED
- 510(k) Number
- K172346 FDA UDI
- FDA Product Code
- LLZ FDA UDI
- EMDN Code
- Z11069005 DIAGNOSTIC IMAGING WORKSTATIONS EUDAMEDZ11030592 RADIOLOGY INSTRUMENTS - MEDICAL DEVICE SOFTWARE EUDAMED
- GMDN Term
- Basic diagnostic x-ray system application software FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA UDI
- Regulation Number
- 892.2050 FDA UDI
- Special Device Type
- Software EUDAMED
- Market of Registration
- France 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
Yes
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 UDIFDA UDI
Serial Number
Yes
FDA UDIFDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDIFDA UDI
Category: Tissue specimen x-ray system IVD
sterEOS by Eos Imaging — Class IIa — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
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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 | 3663999RWS01A5 | Class IIa | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | Pending data |
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Manufacturer
- Manufacturer
- EOS imaging
- EUDAMED SRN
- FR-MF-000000502
Sources (4)
- EUDAMED 925674ef-250b-46cb-8f6b-95891d90effb 61 fields · synced Jul 18, 2026
- FDA UDI cd0e0fcd-a9cc-4aae-a1a5-fe483e0fb705 35 fields · synced May 27, 2026
- FDA UDI dbeba98a-3ddb-47d4-ac0c-46ac8ab91025 33 fields · synced May 30, 2026
- EUDAMED 5c201947-2c9b-4293-90d9-78ffc04b1c71 61 fields · synced Jul 9, 2026