Breathing Filter
by Ningbo Luke Medical Devices Co., LTD 10 variants
Ref CKA-11
Breathing Filter (CKA-11) is a Class IIa device made by Ningbo Luke Medical Devices Co., LTD, registered in EUDAMED on 20 May 2026 (Basic UDI-DI 697024089BFWY), active as of 24 Oct 2026.
Active
CE MDR
Valid until
No date given
FDA recalls
Not applicable
Documents
None linked in EUDAMED
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | Number697024089BFWY 06970240894698 | Date20 May 2026 | StatusActive |
Official records
- EUDAMED public site 697024089BFWY
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
European Union — CE/MDR Active
Specification
- Device name
- Breathing Filter
- Model / reference
- CKA-11
- Primary DI / UDI-DI
- 06970240894698
- Basic UDI-DI
- 697024089BFWY
- Direct marketing DI
- 06970240894698
- EMDN code
- R040101 Antibacterial and antiviral respiratory filters
- Device class
- Class IIa
- EU registration type
- Standard device
- EU market of registration
- Romania
Manufacturer details
- EUDAMED SRN
- CN-MF-000011732
- Authorised representative
- Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001
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