EU Manufacturer
🇨🇳 China
Active
Shenzhen PRO HITU Medical Co., Ltd.
SRN: CN-MF-000021578
·
North face, D area, 1/F, Haowei Building, No.28, 2 North Keji Rd, New&High-Tech Zone, Nanshan District Shenzhen, 518067 Guangdong, P.R. China, 518067 Shenzhen, China
Basic UDI-DIs
1
Total Devices
1
On Market
1
Off Market
0
Certificates
1
Valid
0
Expiring < 6mo
0
Countries
1
Basic Information
- Address
- North face, D area, 1/F, Haowei Building, No.28, 2 North Keji Rd, New&High-Tech Zone, Nanshan District Shenzhen, 518067 Guangdong, P.R. China, 518067 Shenzhen, China
- [email protected]
- Phone
- +86-0755-8651 0800
- Website
- http://www.pro-hifu.com/
Regulatory Overview
Regulation
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Eu Mdd
1
Classification
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Eu Md Class 2b
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Expired / Withdrawn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) | 7074GB410200529 | DNV MEDCERT GmbH | May 27, 2024 |
Market Presence
Devices from this manufacturer are available in 1 country across Europe.
🇩🇪 Germany
Device Portfolio
| Name | ||||
|---|---|---|---|---|
| High Intensity Focused Ultrasound System | EU MDD | Eu Md Class 2b | On Market | 1 |