EU Manufacturer
๐ง๐ช Belgium
Active
Axinesis
SRN: BE-MF-000018870
ยท
Avenue Sabin 3, 1300 Wavre, Belgium
Basic UDI-DIs
4
Total Devices
5
On Market
5
Off Market
0
Certificates
1
Valid
0
Expiring < 6mo
0
Countries
9
Basic Information
- Address
- Avenue Sabin 3, 1300 Wavre, Belgium
- [email protected]
- Phone
- +32(0)10 226 426
- Website
- www.axinesis.com
Regulatory Overview
Regulation
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Eu Mdr
3
Eu Mdd
1
Classification
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Eu Md Class 1
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Expired / Withdrawn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) | BE15/223575945 | SGS Belgium NV | Oct 06, 2023 |
Market Presence
Devices from this manufacturer are available in 9 countries across Europe.
๐ง๐ช Belgium
๐ฉ๐ช Germany
๐ฉ๐ฐ Denmark
๐ช๐ช Estonia
๐ซ๐ฎ Finland
๐ซ๐ท France
๐ณ๐ฑ Netherlands
๐ณ๐ด Norway
๐ต๐ฑ Poland
Device Portfolio
| Name | ||||
|---|---|---|---|---|
| REAplan | EU MDD | Eu Md Class 2a | On Market | 1 |
| REAtouch | EU MDR | Eu Md Class 1 | On Market | 0 |
| REAtouch Lite | EU MDR | Eu Md Class 1 | On Market | 0 |
| REAtouch Oboc | EU MDR | Eu Md Class 1 | On Market | 0 |
| touchLAB | EU MDR | Eu Md Class 1 | On Market | 0 |