Identity
- Device Name
- B650 Software Upgrade EUDAMED
- Model / Reference
- V2.4 EUDAMED2107843-001 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00840682139076 EUDAMED
- Basic UDI-DI
- B-00840682139076 EUDAMED
- EMDN Code
- Z1203020282 MULTI-PARAMETER MONITORS - SOFTWARE ACCESSORIES EUDAMED
Classification
- Device Class
- Class IIb EUDAMED
- Special Device Type
- -1192 EUDAMED
- Market of Registration
- Finland EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
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
B650 Software Upgrade by GE Healthcare Finland Oy — Class IIb — MDD — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-00840682139076 | Class IIb | Active |
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Manufacturer
- Manufacturer
- GE Healthcare Finland Oy
- EUDAMED SRN
- FI-MF-000001176
Sources (1)
- EUDAMED 8e6d88a1-9afb-45fd-9f8d-de2dc5cbfd3f 61 fields · synced Oct 7, 2026