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Carescape Software
EUDAMEDClass IIb (EU MDR)
Ref 5956035Model Version 4 (build 4.0)
Identity
- Trade Name
- Carescape Software EUDAMED
- Device Name
- Carescape Software EUDAMED
- Model / Reference
- Version 4 (build 4.0) EUDAMED5956035 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00195278875570 EUDAMED
- Basic UDI-DI
- 08406821BUG006157B EUDAMED
- EMDN Code
- Z1203020282 MULTI-PARAMETER MONITORS - SOFTWARE ACCESSORIES EUDAMED
Classification
- Device Class
- Class IIb EUDAMED
- Special Device Type
- Software EUDAMED
- Market of Registration
- Finland EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
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
Carescape Software by GE Healthcare Finland Oy — Class IIb — MDR — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 08406821BUG006157B | Class IIb | Active |
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Manufacturer
- Manufacturer
- GE Healthcare Finland Oy
- EUDAMED SRN
- FI-MF-000001176
Sources (1)
- EUDAMED 09754110-3e95-4d2a-9e95-7f1e35236337 61 fields · synced Oct 7, 2026