Sih 09
by Globalcare Medical Technology Co., Ltd. China EUDAMED
Ref 871.21
EMDN Z12159002
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | Number697022925GCE8XXEM | Date10 Dec 2025 | StatusActive |
Coverage
- Active
- Not covered
European Union — CE/MDR Active
Specification
- Device Name
- Aerosoltherapy Nebulizer
- Model / Reference
- 871.21
- Primary DI / UDI-DI
- 06970229254802
- Basic UDI-DI
- 697022925GCE8XXEM
- Direct Marketing DI
- 06970229254802
- EMDN Code
- Z12159002 Aerosol equipment
- Device Class
- Class IIa
- Market of Registration
- Germany
Manufacturer details
- EUDAMED SRN
- CN-MF-000033595
- Authorised representative
- Donawa Lifescience Consulting Srl IT-AR-000007785
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Properties & raw data
Show properties, registry sources and raw records
Other properties (12)
- 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
- Measuring Function: No
- Incorporates Medicinal Product: No
Sources (1)
- EUDAMED 06970229254802|697022925GCE8XXEM