CareIntellect MUSE
by GE Medical Systems Information Technologies, Inc. United States EUDAMED
Ref 5970545-001Model CareIntellect MUSE
EMDN Z12050392
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | Number08406821BUG005807H | Date6 Jan 2026 | StatusActive |
Coverage
- Active
- Not covered
European Union — CE/MDR Active
Specification
- Model / Reference
- CareIntellect MUSE, 5970545-001
- Primary DI / UDI-DI
- 00198953041741
- Basic UDI-DI
- 08406821BUG005807H
- EMDN Code
- Z12050392 Electrocardiographs - medical device software
- Device Class
- Class IIa
- Special Device Type
- Software
- Market of Registration
- Italy
Manufacturer details
- EUDAMED SRN
- US-MF-000017529
- Authorised representative
- GE Medical Systems SCS FR-AR-000000344
Other devices from Ge Medical Systems Information Technologies, Inc.
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Properties & raw data
Show properties, registry sources and raw records
Other properties (13)
- Sterile: No
- Implantable: No
- Reusable: No
- Contains Latex: No
- Reprocessed: No
- CMR Substance: No
- Human-derived: No
- Human Tissues: No
- Animal Tissues: No
- Endocrine Disruptor: No
- Administering Medicine: No
- Measuring Function: No
- Incorporates Medicinal Product: No
Sources (1)
- EUDAMED c0da311f-078f-47b4-8f7e-cb272bd85b43