Identity
- Trade Name
- CARESCAPE Gateway EUDAMED
- Device Name
- CARESCAPE Gateway V2.3 EUDAMED
- Model / Reference
- 5697315-002 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00195278888235 EUDAMED
- Basic UDI-DI
- 08406821BUG005287F EUDAMED
- Direct Marketing DI
- 00195278888235 EUDAMED
- EMDN Code
- Z1203020292 MULTI-PARAMETER MONITORS - MEDICAL DEVICE SOFTWARE EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Special Device Type
- Software EUDAMED
- Market of Registration
- Austria 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
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
CARESCAPE Gateway by Ge Medical Systems Information Technologies, Inc. — Class I — 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 | 08406821BUG005287F | Class I | Active |
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Manufacturer
- Manufacturer
- GE Medical Systems Information Technologies, Inc.
- EUDAMED SRN
- US-MF-000017529
- Authorised Representative
- GE Medical Systems SCS FR-AR-000000344
Sources (1)
- EUDAMED 89a47309-1b32-41db-947e-10d28e91c926 61 fields · synced Jun 19, 2026