Polymed
by Ningbo Boya Medical Equipment Co., Ltd 9 variants
Ref BY-5Model BY-RGB-P-1/BY-RGB-P-2/BY-RGB-P-3/BY-GL-1/BY-GL-2/ BY-GL-3/BY-GL-4/BY-GL-5/BY-1/BY-2/BY-3/BY-4/BY-5
Active
CE MDR
Valid until
Not listed
FDA recalls
Not applicable
Documents
None linked in EUDAMED
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | Number69514674110001VX 06951467491136 | Date8 Oct 2024 | StatusActive |
Certificates
EUDAMED lists no certificate for this device's Basic UDI-DI.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
European Union — CE/MDR Active
Specification
- Model / Reference
- BY-RGB-P-1/BY-RGB-P-2/BY-RGB-P-3/BY-GL-1/BY-GL-2/ BY-GL-3/BY-GL-4/BY-GL-5/BY-1/BY-2/BY-3/BY-4/BY-5, BY-5
- Primary DI / UDI-DI
- 06951467491136
- Basic UDI-DI
- 69514674110001VX
- EMDN Code
- R040102 Antibacterial and antiviral respiratory filters humidifiers
- Device Class
- Class IIa
- EU market of registration
- Germany
Manufacturer details
- EUDAMED SRN
- CN-MF-000032282
- Authorised representative
- Caretechion GmbH DE-AR-000005946
Other devices from Ningbo Boya Medical Equipment Co., Ltd
See all devices from Ningbo Boya Medical Equipment Co., Ltd →
Properties
Other properties (12)
- 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