Ultra-Quiet Portable Nebulizers
by Shenzhen Fitconn Technology Co., ltd China EUDAMED
Ref MY-123Model MY-123, MY-130, MY-132, MY-133, MY-135, MY-123B, MY-130B, MY-132B, MY 133B, MY-135B
EMDN Z12040210
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | NumberFI26/1008022 | Date1 Jul 2026 | StatusActive |
Coverage
- Active
- Not covered
European Union — CE/MDR Active
Certificates
- FI26/1008022 Supplemented
Quality management system EU MDR
- Notified body
- SGS FIMKO OY 0598
- Issued
- 1 Jul 2026
- Expires
- 16 Apr 2031
- Reason
- Other
Specification
- Device Name
- Mesh Nebulizer
- Model / Reference
- MY-123, MY-130, MY-132, MY-133, MY-135, MY-123B, MY-130B, MY-132B, MY 133B, MY-135B
- Primary DI / UDI-DI
- 06970470480746
- Basic UDI-DI
- 697047048MYNEBQ8
- Direct Marketing DI
- 06970470480746
- EMDN Code
- Z12040210 Ultrasonic nebulisers
- Device Class
- Class IIa
- Market of Registration
- Spain
Manufacturer details
- EUDAMED SRN
- CN-MF-000024538
- Authorised representative
- Wellkang Ltd XI-AR-000001836
Other devices from Shenzhen Fitconn Technology Co., ltd
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 b77e6e18-4599-45c4-a6fc-00b00d59d4e8