Actimi Signals
by ACTIMI GmbH Germany EUDAMED
Ref SIG
EMDN Z1203020692
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | NumberMDR-0028 | Date26 Feb 2026 | StatusActive |
Coverage
- Active
- Not covered
European Union — CE/MDR Active
Certificates
- MDR-0028 Supplemented
Quality management system EU MDR
- Notified body
- SLOVENIAN INSTITUTE OF QUALITY AND METROLOGY - SIQ 1304
- Issued
- 26 Feb 2026
- Expires
- 10 Mar 2030
- Reason
- Change approved
Specification
- Model / Reference
- SIG
- Primary DI / UDI-DI
- 04270003120319
- Basic UDI-DI
- 42700031203-API-XG
- EMDN Code
- Z1203020692 Vital signs telemetry instruments - medical device software
- Device Class
- Class IIa
- Special Device Type
- Software
- Market of Registration
- Germany
Manufacturer details
- EUDAMED SRN
- DE-MF-000024271
Other devices from ACTIMI GmbH
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 f8aee262-6d4b-4afb-b799-18c22a0d0794