Zeno AI
by WSK Medical Netherlands EUDAMED
Ref 1
EMDN Z12149092
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | NumberZ-24-118-S-IX-E | Date15 Apr 2026 | StatusActive |
Coverage
- Active
- Not covered
European Union — CE/MDR Active
Certificates
- Z-24-118-S-IX-E Issued
Quality management system EU MDR
- Notified body
- Notified body 0633
- Issued
- 15 Apr 2026
- Expires
- 14 Aug 2027
Specification
- Model / Reference
- 1
- Primary DI / UDI-DI
- +G739ZENOAI0102X00L, 08720299581012, +G739ZENOAI0103X00L
- Basic UDI-DI
- ++G739ZenoAIYB, 63057138720299581012RJ
- Direct Marketing DI
- +G739ZENOAI0102X00L+G739ZENOAI0103X00L
- EMDN Code
- Z12149092 Various ENT instruments - medical device software
- Device Class
- Class IIb
- Special Device Type
- Software
- Market of Registration
- Netherlands
Manufacturer details
- EUDAMED SRN
- NL-MF-000010947
Other devices from WSK Medical
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 (3)
- EUDAMED b76ea1f6-1a97-460d-9d4e-5edeef5e4b77
- EUDAMED 08720299581012|63057138720299581012RJ
- EUDAMED +G739ZENOAI0103X00L|63057138720299581012RJ