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Mobile Care, Web Viewer
EUDAMEDFDA UDIClass IIb (EU MDR)
Ref Mobile Care Software LicensesModel V6.3
Identity
- Trade Name
- Mobile Care, Web Viewer EUDAMEDMobile Care FDA UDI
- Generic Name
- Centralized patient monitor FDA UDI
- Device Name
- Mobile Care Software EUDAMED
- Model / Reference
- V6.3 EUDAMEDMobile Care Software Licenses EUDAMEDWeb Viewer FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00840682106498 EUDAMEDFDA UDI
- Basic UDI-DI
- B-00840682106498 EUDAMED
- FDA Product Code
- MSX FDA UDI
- EMDN Code
- Z1203020282 MULTI-PARAMETER MONITORS - SOFTWARE ACCESSORIES EUDAMED
- GMDN Term
- Centralized patient monitor FDA UDI
Classification
- Device Class
- Class IIb EUDAMEDClass II FDA UDI
- Regulation Number
- 870.2300 FDA UDI
- Special Device Type
- -1192 EUDAMED
- Market of Registration
- Finland 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
No
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
Mobile Care, Web Viewer by GE Healthcare Finland Oy — Class IIb — 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-00840682106498 | Class IIb | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIb | Pending data |
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Manufacturer
- Manufacturer
- GE Healthcare Finland Oy
- EUDAMED SRN
- FI-MF-000001176
Sources (2)
- EUDAMED 933157f7-a483-4e9c-b11d-c191e514842b 61 fields · synced Oct 6, 2026
- FDA UDI 63af9ec9-cb69-4779-a6ef-61adab0295f9 33 fields · synced May 26, 2026