Identity
- Trade Name
- Universal Viewer v8 EUDAMEDUniversal Viewer FDA UDI
- Generic Name
- Medical image management system FDA UDI
- Device Name
- Universal Viewer EUDAMEDMD UV 8 MEDICAL DEVICE FDA UDI
- Model / Reference
- K2049DE EUDAMED8 FDA UDI
- Description
- MD UV 8 MEDICAL DEVICE FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00195278379610 EUDAMEDFDA UDI
- Basic UDI-DI
- B-00195278379610 EUDAMED
- 510(k) Number
- K211312 FDA UDI
- FDA Product Code
- LLZ FDA UDI
- EMDN Code
- Z110603 PICTURE ARCHIVING AND COMMUNICATION SYSTEMS EUDAMED
- GMDN Term
- Medical image management system FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA UDI
- Regulation Number
- 892.2050 FDA UDI
- Special Device Type
- -1192 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
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
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
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Universal Viewer v8 by GE Healthcare — Class IIa — FDA_510K, MDD — listed in EUDAMED, FDA GUDID, FDA 510(k) — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
United States Active
FDA_510K
European Union Active
CE/MDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K211312 | Class IIa | Active |
| EUDAMED | European Union | CE/MDD | B-00195278379610 | Class IIa | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- GE Healthcare
- EUDAMED SRN
- US-MF-000001862
- Authorised Representative
- GE Medical Systems SCS FR-AR-000000344
Sources (3)
- EUDAMED 5de72478-bad1-4552-bacc-963e7913e9bb 61 fields · synced Oct 6, 2026
- FDA UDI c7ecf98e-0faa-46ba-9b32-4ce11b42784b 34 fields · synced May 30, 2026
- FDA 510(k) K211312 1 fields · synced May 18, 2026