Identity
- Trade Name
- Universal Viewer 8.1 EUDAMEDUniversal Viewer FDA UDI
- Generic Name
- Medical image management system FDA UDI
- Device Name
- Universal Viewer EUDAMEDMD UV 8.1 MEDICAL DEVICE FDA UDI
- Model / Reference
- 5865733-001 EUDAMED8.1 FDA UDI
- Description
- MD UV 8.1 MEDICAL DEVICE FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00195278644039 EUDAMEDFDA UDI
- Basic UDI-DI
- 8406821BUG00216H5 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
- 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
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Universal Viewer 8.1 by GE Healthcare — 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 | 8406821BUG00216H5 | Class IIa | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | Pending data |
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Manufacturer
- Manufacturer
- GE Healthcare
- EUDAMED SRN
- US-MF-000001862
- Authorised Representative
- GE Medical Systems SCS FR-AR-000000344
Sources (2)
- EUDAMED 85f10ef6-def1-4711-929e-879185c8d0eb 61 fields · synced Jul 11, 2026
- FDA UDI 8d7f54dc-e5d0-40b6-8458-cafa5c6cbd7a 34 fields · synced May 30, 2026