← Back to catalogue
Disposable sterile medical mask
EUDAMEDClass I (EU MDR)
Ref KF-B P01(WK-BD-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) Ref KF-B P01(II-EO)Ref KF-B P08(WK-BD-EO)Ref KF-B P01(EN-EO)Ref KF-B P08(WK-EO)
Identity
- Device Name
- Disposable sterile medical mask EUDAMED
- 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) EUDAMEDKF-B P01(WK-BD-EO) EUDAMEDKF-B P01(II-EO) EUDAMEDKF-B P08(WK-BD-EO) EUDAMEDKF-B P01(EN-EO) EUDAMEDKF-B P08(WK-EO) EUDAMED
Identifiers
- Primary DI / UDI-DI
- 16976739564193 EUDAMED16976739564155 EUDAMED16976739564209 EUDAMED16976739564148 EUDAMED16976739564179 EUDAMED
- Basic UDI-DI
- 697673956KF-BSU EUDAMED
- EMDN Code
- T020604 MEDICAL USE FACE MASKS, TYPE II AND IIR EUDAMEDT020603 MEDICAL USE FACE MASKS, TYPE I (NOT FOR HEALTHCARE PROFESSIONALS) EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Germany EUDAMED
Clinical & Handling
Sterile
Yes
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Disposable sterile medical mask by Guangdong Kingfa Sci. & Tech. Co., Ltd. — Class I — MDR — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 697673956KF-BSU | Class I | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Guangdong Kingfa Sci. & Tech. Co., Ltd.
- EUDAMED SRN
- CN-MF-000009520
- Authorised Representative
- Share info GmbH DE-AR-000005132
Sources (5)
- EUDAMED a952473f-2f3b-435d-aa18-7c4b9d7873bb 61 fields · synced Jul 31, 2026
- EUDAMED 3522c67b-1370-4940-931a-cb2941060702 61 fields · synced May 17, 2026
- EUDAMED 4568eef2-0b5b-46b0-96ed-2665ce6937fa 61 fields · synced May 18, 2026
- EUDAMED 1c6dee74-4aef-4398-8025-fdc0e47dbb45 61 fields · synced May 18, 2026
- EUDAMED 23cde5e9-ed3d-47b1-8810-38e7aded7ee3 61 fields · synced May 19, 2026