EU Manufacturer
๐ง๐ช Belgium
Active
Medisoft S.A.
SRN: BE-MF-000000789
ยท
Rue du Clairon 5, 5503 Sorinnes, Belgium
Basic UDI-DIs
11
Total Devices
11
On Market
10
Off Market
1
Certificates
1
Valid
0
Expiring < 6mo
0
Countries
20
Basic Information
- Address
- Rue du Clairon 5, 5503 Sorinnes, Belgium
- [email protected]
- Phone
- +3282223020
- Website
- www.medisoft.be
Regulatory Overview
Regulation
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Eu Mdd
9
Eu Ivdr
2
Classification
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Eu Md Class 2a
9
Eu Ivd Class A
2
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Expired / Withdrawn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) | 1434-MDD-380/2019 | POLSKIE CENTRUM BADAN I CERTYFIKACJI S.A. | Jul 17, 2024 |
Market Presence
Devices from this manufacturer are available in 20 countries across Europe.
๐ฆ๐น Austria
๐ง๐ช Belgium
๐ง๐ฌ Bulgaria
๐จ๐พ Cyprus
๐จ๐ฟ Czechia
๐ฉ๐ช Germany
๐ฌ๐ท Greece
๐ช๐ธ Spain
๐ซ๐ท France
๐ญ๐ท Croatia
๐ญ๐บ Hungary
๐ฎ๐ช Ireland
๐ฎ๐น Italy
๐ฑ๐น Lithuania
๐ฑ๐บ Luxembourg
๐ณ๐ฑ Netherlands
๐ต๐ฑ Poland
๐ต๐น Portugal
๐ธ๐ฎ Slovenia
๐ฌ๐ง United Kingdom
Device Portfolio
| Name | ||||
|---|---|---|---|---|
| BodyBox PFS | EU MDD | Eu Md Class 2a | On Market | 1 |
| Ergocard CPX Clinical | EU MDD | Eu Md Class 2a | On Market | 1 |
| Ergocard CPX Professional | EU MDD | Eu Md Class 2a | On Market | 1 |
| Expair | EU MDD | Eu Md Class 2a | On Market | 1 |
| FeNo+ PFS | EU MDD | Eu Md Class 2a | On Market | 1 |
| HypAir PFS | EU MDD | Eu Md Class 2a | On Market | 1 |
| Micro 5000 PFS | EU MDD | Eu Md Class 2a | On Market | 1 |
| Micro 6000 | EU MDD | Eu Md Class 2a | On Market | 1 |
| SpiroAir | EU MDD | Eu Md Class 2a | On Market | 1 |
| VARIOUS GENERAL PURPOSE IVD INSTRUMENTS - OTHER | EU IVDR | Eu Ivd Class A | Off Market | 0 |
| VARIOUS GENERAL PURPOSE IVD INSTRUMENTS - OTHER | EU IVDR | Eu Ivd Class A | On Market | 0 |