Identity
- Trade Name
- MEDWS EUDAMEDFDA UDI
- Generic Name
- Diagnostic x-ray digital imaging system workstation application software FDA UDI
- Device Name
- MEDWS EUDAMED
- Model / Reference
- MEDWS EUDAMED7.4 EUDAMEDFDA UDI
Identifiers
- Primary DI / UDI-DI
- 03665587000149 EUDAMEDFDA UDI
- Basic UDI-DI
- 3665587DIAGNOSIS0000001LD EUDAMED
- Direct Marketing DI
- 03665587000149 EUDAMED
- 510(k) Number
- K132684 FDA UDI
- FDA Product Code
- LLZ FDA UDI
- EMDN Code
- V92 MEDICAL DEVICE SOFTWARE - NOT INCLUDED IN OTHER CLASSES EUDAMED
- GMDN Term
- Diagnostic x-ray digital imaging system workstation 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
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
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Medws by Med.e.com — Class IIa — 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 | 3665587DIAGNOSIS0000001LD | Class IIa | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | Pending data |
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Manufacturer
- Manufacturer
- MED.e.Com
- EUDAMED SRN
- FR-MF-000003036
Sources (2)
- EUDAMED 5cd13aa4-0c10-4d62-a950-09751401d30f 61 fields · synced Jul 18, 2026
- FDA UDI 202c8c99-807e-4b0a-8160-ef29edadae33 34 fields · synced May 29, 2026