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Centricity Universal Viewer 7.0
EUDAMEDFDA UDIClass IIa (EU MDR)
Ref K1221JED/P1221JED/K1221KJED/P1221KJED
Identity
- Trade Name
- Centricity Universal Viewer 7.0 EUDAMEDCENTRICITY FDA UDI
- Generic Name
- Medical image management system FDA UDI
- Device Name
- Centricity Universal Viewer EUDAMED
- Model / Reference
- K1221JED/P1221JED/K1221KJED/P1221KJED EUDAMEDUNIVERSAL VIEWER 7.0 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00840682145794 EUDAMEDFDA UDI
- Basic UDI-DI
- B-00840682145794 EUDAMED
- 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
Centricity Universal Viewer 7.0 by GE Healthcare — Class IIa — MDD, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDD
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-00840682145794 | 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 ef94ee27-1761-4b9a-b06f-fb0fb6d3234f 61 fields · synced Jun 18, 2026
- FDA UDI 907ae722-ee6a-45bb-bd37-76b641fc3e70 33 fields · synced May 30, 2026