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UV Phototherapy
EUDAMEDFDA 510(k)Class IIa (EU MDR)
Ref 06928798620078Model KN-4003AL2Ref 06928798620283Model KN-4006BL1DRef 06928798620085Model KN-4003BL2Ref 06928798620276Model KN-4006AL1DRef 06928798620269Model KN-4006BL1Ref 06928798620092Model KN-4003AL2DRef 06928798620108Model KN-4003BL2D
Identity
- Trade Name
- UV Phototherapy EUDAMED
- Model / Reference
- KN-4003AL2 EUDAMED06928798620078 EUDAMEDKN-4006BL1D EUDAMED06928798620283 EUDAMEDKN-4003BL2 EUDAMED06928798620085 EUDAMEDKN-4006AL1D EUDAMED06928798620276 EUDAMEDKN-4006BL1 EUDAMED06928798620269 EUDAMEDKN-4003AL2D EUDAMED06928798620092 EUDAMEDKN-4003BL2D EUDAMED06928798620108 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06928798620078 EUDAMED06928798620283 EUDAMED06928798620085 EUDAMED06928798620276 EUDAMED06928798620269 EUDAMED06928798620092 EUDAMED06928798620108 EUDAMED
- Basic UDI-DI
- B-06928798620078 EUDAMEDB-06928798620283 EUDAMEDB-06928798620085 EUDAMEDB-06928798620276 EUDAMEDB-06928798620269 EUDAMEDB-06928798620092 EUDAMEDB-06928798620108 EUDAMED
- EMDN Code
- Z120614 INFRARED ULTRAVIOLET RAY LAMPS EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Germany EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
Yes
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
UV Phototherapy by Xuzhou Kernel Medical Equipment Co., Ltd. — Class IIa — FDA_510K, MDD — listed in EUDAMED, FDA 510(k) — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
United States Active
FDA_510K
United States Active
FDA_510K
European Union Active
CE/MDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K132643 | Class IIa | Active |
| FDA 510(k) | United States | FDA_510K | K181805 | Class IIa | Active |
| EUDAMED | European Union | CE/MDD | B-06928798620078 | Class IIa | Active |
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Manufacturer
- Manufacturer
- Xuzhou Kernel Medical Equipment Co., Ltd.
- EUDAMED SRN
- CN-MF-000020694
- Authorised Representative
- Caretechion GmbH DE-AR-000005946
Sources (8)
- EUDAMED 1cbef0a7-3019-448f-8e2e-1a4a370432ef 61 fields · synced Jul 26, 2026
- EUDAMED 667f870b-43e5-4910-ae9a-7be0720d769d 61 fields · synced May 17, 2026
- EUDAMED aaef2ca5-318c-4898-8869-bb57e50d943c 61 fields · synced May 17, 2026
- EUDAMED 059d2f4f-3d21-4e4c-8e56-243ce3b5e69a 61 fields · synced May 17, 2026
- EUDAMED 2077b052-7093-4b3e-8f99-6a74b047c1b7 61 fields · synced May 18, 2026
- EUDAMED de6fed33-557a-42b1-9cb5-51e37e260af2 61 fields · synced May 18, 2026
- EUDAMED 4f1e4361-8962-483f-9766-1a0fbd9a18ff 61 fields · synced May 18, 2026
- FDA 510(k) K132643 1 fields · synced May 18, 2026