EU Manufacturer
🇨🇳 China
Xuzhou Kernel Medical Equipment Co.,Ltd.
SRN: CN-MF-000020694
·
Kernel Mansion, Economic Development District, 221004 Xuzhou (Jiangsu), China
Basic UDI-DIs
5
Total Devices
5
On Market
5
Off Market
0
Certificates
2
Valid
0
Expiring < 6mo
0
Countries
1
Basic Information
- Address
- Kernel Mansion, Economic Development District, 221004 Xuzhou (Jiangsu), China
- [email protected]
- Phone
- +86 0 516-87732212
Regulatory Overview
Regulation
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Eu Mdd
3
Eu Mdr
2
Classification
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Eu Md Class 2a
3
Eu Md Class 1
2
Device Types
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Certificate Health
Total
2
Valid
0
Expiring < 6mo
0
Expired / Withdrawn
0
Certificates by Expiry Year
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| Type | Number | Expiry Date | Status | |||
|---|---|---|---|---|---|---|
| MDD Annex II (excluding section 4) | 9852-2017-CE-RGC-NA-PS Rev. 1.0 | DNV Product Assurance AS | Dec 31, 2028 | |||
| MDD Annex II (excluding section 4) | 9852-2017-CE-RGC-NA-PS Rev.1.0 | DNV Product Assurance AS | Dec 31, 2028 |
Market Presence
Devices from this manufacturer are available in 1 country across Europe.
🇩🇪 Germany
Device Portfolio
| Name | ||||
|---|---|---|---|---|
| Colposcope System | EU MDR | Eu Md Class 1 | On Market | 0 |
| PHOTODYNAMIC THERAPY DEVICE | EU MDD | Eu Md Class 2a | On Market | 1 |
| PHOTODYNAMIC THERAPY DEVICE | EU MDD | Eu Md Class 2a | On Market | 1 |
| Photodynamic Therapeutic Devices | EU MDD | Eu Md Class 2a | On Market | 1 |
| Wood' lamp | EU MDR | Eu Md Class 1 | On Market | 0 |