Three Balls Spirometer
by Zhenjiang R&X Technology Co., Ltd. China EUDAMED
Ref RX-1402
EMDN R900902
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | Number697816810TBSpiroSC | Date19 Mar 2025 | StatusActive |
Coverage
- Active
- Not covered
European Union — CE/MDR Active
Specification
- Device Name
- Three Balls Spirometer
- Model / Reference
- RX-1402
- Primary DI / UDI-DI
- 06978168100051
- Basic UDI-DI
- 697816810TBSpiroSC
- EMDN Code
- R900902 Inspiratory and expiratory flow stimulators/respiratory muscles trainers
- Device Class
- Class I
- Market of Registration
- Poland
Manufacturer details
- EUDAMED SRN
- CN-MF-000046841
- Authorised representative
- SUNGO Europe B.V. NL-AR-000000247
Other devices from Zhenjiang R&X 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 10fc8583-7b45-4112-bd0a-c38e69656173