Breathing Filters for Single Use
by Haiyan Kangyuan Medical Instrument Co., Ltd.
Ref /
Breathing Filters for Single Use is a Class IIa device made by Haiyan Kangyuan Medical Instrument Co., Ltd., registered in EUDAMED on 29 Sep 2026 (Basic UDI-DI 6948097015GLQJS) with CE/MDR certificate 6122159CE01 valid until 1 Feb 2028, active as of 25 Oct 2026.
Active
CE MDR
Valid until
1 Feb 2028
FDA recalls
Not applicable
Documents
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | Number6948097015GLQJS 06948097057504 | Date29 Sep 2026 | StatusActive |
Official records
- EUDAMED public site 6948097015GLQJS
Certificates
- 6122159CE01 Active
Quality management system EU MDR
- Certifier
- DEKRA Certification B.V. 0344
- Issued
- 10 Apr 2025
- Expires
- 1 Feb 2028
- Reason
- Add device or group
Timeline
- Certificate issued EUDAMED 6122159CE01
- Registered EUDAMED 6948097015GLQJS
- Certificate expires EUDAMED 6122159CE01
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
European Union — CE/MDR Active
Specification
- Device name
- Breathing Filters for Single Use
- Model / reference
- /
- Primary DI / UDI-DI
- 06948097057504
- Basic UDI-DI
- 6948097015GLQJS
- EMDN code
- R040299 Natural breathing filters - other
- Device class
- Class IIa
- EU registration type
- Standard device
- EU market of registration
- Germany
Manufacturer details
- EUDAMED SRN
- CN-MF-000001532
- Authorised representative
- Eunitor GmbH DE-AR-000005081
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