EU Manufacturer
๐จ๐ณ China
Active
BioRegen Biomedical (Changzhou) Co., Ltd.
SRN: CN-MF-000007975
ยท
Building B, No. 117, Xueye Road, 213125 Changzhou, Jiangsu, China
Basic UDI-DIs
4
Total Devices
4
On Market
4
Off Market
0
Certificates
4
Valid
0
Expiring < 6mo
0
Countries
18
Basic Information
- Address
- Building B, No. 117, Xueye Road, 213125 Changzhou, Jiangsu, China
- [email protected]
- Phone
- +86-519-88408555
- Website
- http://www.bioregenmed.com
Regulatory Overview
Regulation
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Eu Mdd
4
Classification
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Eu Md Class 2a
3
Eu Md Class 3
1
Certificate Health
Total
4
Valid
0
Expiring < 6mo
0
Expired / Withdrawn
4
Certificates by Expiry Year
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| Type | Number | Expiry Date | Status | |||
|---|---|---|---|---|---|---|
| MDD Annex II (excluding section 4) | G10703400007 | TรV SรD Product Service GmbH | May 25, 2024 | |||
| MDD Annex II Section 4 | G70703400009 | TรV SรD Product Service GmbH | May 25, 2024 | |||
| MDD Annex V | G20703400010 | TรV SรD Product Service GmbH | May 25, 2024 | |||
| MDD Annex V | DD 60149398 0001 | TรV Rheinland LGA Products GmbH | May 26, 2024 |
Market Presence
Devices from this manufacturer are available in 18 countries across Europe.
๐ฆ๐น Austria
๐ง๐ช Belgium
๐ง๐ฌ Bulgaria
๐จ๐พ Cyprus
๐ฉ๐ช Germany
๐ฉ๐ฐ Denmark
๐ฌ๐ท Greece
๐ช๐ธ Spain
๐ซ๐ฎ Finland
๐ซ๐ท France
๐ฎ๐น Italy
๐ฑ๐บ Luxembourg
๐ณ๐ฑ Netherlands
๐ณ๐ด Norway
๐ต๐ฑ Poland
๐ต๐น Portugal
๐น๐ท Tรผrkiye
๐ฌ๐ง United Kingdom
Device Portfolio
| Name | ||||
|---|---|---|---|---|
| MateRegen Gel | EU MDD | Eu Md Class 2a | On Market | 1 |
| MateRegen Gel | EU MDD | Eu Md Class 2a | On Market | 1 |
| NON-ADHERENT ABSORBENT DRESSINGS | EU MDD | Eu Md Class 3 | On Market | 3 |
| PureRegen Gel Sinus | EU MDD | Eu Md Class 2a | On Market | 1 |