EU Manufacturer
🇨🇳 China
Active
Royal Fornia Medical Equipment Co.,Ltd.
SRN: CN-MF-000008628
·
Fornia Tech Park, NO.18, Kejiyi Road, Hi-Tech innovation Coast, Tangjia Bay NO.18, 519085 Zhuhai, Guangdong Province, China
Basic UDI-DIs
4
Total Devices
4
On Market
4
Off Market
0
Certificates
1
Valid
0
Expiring < 6mo
0
Countries
2
Basic Information
- Address
- Fornia Tech Park, NO.18, Kejiyi Road, Hi-Tech innovation Coast, Tangjia Bay NO.18, 519085 Zhuhai, Guangdong Province, China
- [email protected]
Regulatory Overview
Regulation
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Eu Mdd
3
Eu Mdr
1
Classification
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Eu Md Class 2b
3
Eu Md Class 2a
1
Device Types
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Certificate Health
Total
1
Valid
0
Expiring < 6mo
0
Expired / Withdrawn
1
Certificates by Expiry Year
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| Type | Number | Expiry Date | Status | |||
|---|---|---|---|---|---|---|
| MDD Annex II (excluding section 4) | G10544660017 | TÜV SÜD Product Service GmbH | May 26, 2024 |
Market Presence
Devices from this manufacturer are available in 2 countries across Europe.
🇪🇸 Spain
🇹🇷 Türkiye
Device Portfolio
| Name | ||||
|---|---|---|---|---|
| Disposable Infusion Pump | EU MDD | Eu Md Class 2b | On Market | 1 |
| Disposable Infusion Pump | EU MDD | Eu Md Class 2b | On Market | 1 |
| Disposable Infusion Pump | EU MDD | Eu Md Class 2b | On Market | 1 |
| ELASTOMERIC SYSTEMS - VARIABLE FLOW W/O ADDITIONAL BOLUS | EU MDR | Eu Md Class 2a | On Market | 0 |