ENTstatistics
by Innoforce Anstalt Liechtenstein EUDAMED
Ref IMIS 6.0, ENTstatistics 5.1, ENTstatistics 5.1.19, IMIS 6.2
EMDN V92,Z12129092,Z12149092
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | Number764029598IMISLQ | Date12 Sep 2025 | StatusActive |
Coverage
- Active
- Not covered
European Union — CE/MDR Active
Certificates
- Z-24-137-S-IX Issued
Quality management system EU MDR
- Notified body
- Notified body 0633
- Issued
- 25 Aug 2025
- Expires
- 14 Aug 2030
Specification
- Device Name
- INNOFORCE Medical Information System
- Model / Reference
- IMIS 6.0, ENTstatistics 5.1, ENTstatistics 5.1.19, IMIS 6.2
- Primary DI / UDI-DI
- 07640295980002, D-ENTstatistics6K, D-ENTstatistics-5.1.19MA, 07640295980019
- Basic UDI-DI
- 764029598IMISLQ, B-ENTstatistics6K, B-ENTstatistics-5.1.19MA
- Direct Marketing DI
- 0764029598000207640295980019
- EMDN Code
- V92,Z12129092,Z12149092, V92,Z12149092, V92,Z12129092
- Device Class
- Class IIaClass I
- Special Device Type
- Software-1192
- Market of Registration
- LiechtensteinGermanyAustria
Manufacturer details
- EUDAMED SRN
- LI-MF-000002047
Other devices from Innoforce Anstalt
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 (4)
- EUDAMED 7340e1d8-9a53-4ff8-803b-4e52c68f2d4d
- EUDAMED D-ENTSTATISTICS6K|B-ENTSTATISTICS6K
- EUDAMED D-ENTSTATISTICS-5.1.19MA|B-ENTSTATISTICS-5.1.19MA
- EUDAMED 07640295980019|764029598IMISLQ