Disposable sterile medical mask
by Guangdong Kingfa Sci. & Tech. Co., Ltd. EUDAMED
Active
Ref KF-B P01(EN-EO)Model KF-B P01(EN-EO) KF-B P01(II-EO) KF-B P01(WK-EO) KF-B P08(WK-EO) KF-B P09(WK-EO) KF-B P01(WK-BD-EO) KF-B P08(WK-BD-EO) KF-B P09(WK-BD-EO)
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | NumberCN26/00002176 | Date30 Mar 2026 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
European Union — CE/MDR Active
Certificates
- CN26/00002176 Issued
Quality assurance EU MDR
- Notified body
- Notified body 1639
- Issued
- 30 Mar 2026
- Expires
- 30 Mar 2031
Specification
- Device Name
- Disposable sterile medical mask
- Model / Reference
- KF-B P01(EN-EO) KF-B P01(II-EO) KF-B P01(WK-EO) KF-B P08(WK-EO) KF-B P09(WK-EO) KF-B P01(WK-BD-EO) KF-B P08(WK-BD-EO) KF-B P09(WK-BD-EO), KF-B P01(EN-EO)
- Primary DI / UDI-DI
- 16976739564148
- Basic UDI-DI
- 697673956KF-BSU
- EMDN Code
- T020603 Medical use face masks, type i (not for healthcare professionals)
- Device Class
- Class I
- Market of Registration
- Germany
Manufacturer details
- EUDAMED SRN
- CN-MF-000009520
- Authorised representative
- Share info GmbH DE-AR-000005132
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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