EU Manufacturer
🇸🇪 Sweden
Active
Magle Chemoswed AB
SRN: SE-MF-000003569
·
Agneslundsvägen 27, 212 15 Malmö, Sweden
Basic UDI-DIs
4
Total Devices
4
On Market
4
Off Market
0
Certificates
4
Valid
0
Expiring < 6mo
0
Countries
14
Basic Information
- Address
- Agneslundsvägen 27, 212 15 Malmö, Sweden
- [email protected]
- Phone
- +46 40 38 33 00
- Website
- https://maglechemoswed.com/
Regulatory Overview
Regulation
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Eu Mdd
4
Classification
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Eu Md Class 2a
2
Eu Md Class 2b
2
Certificate Health
Total
4
Valid
0
Expiring < 6mo
0
Expired / Withdrawn
2
Certificates by Expiry Year
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| Type | Number | Expiry Date | Status | |||
|---|---|---|---|---|---|---|
| MDD Annex II (excluding section 4) | 145067-21-01-21 | CE Certiso Orvos- és Kórháztechnikai Ellenőrző és Tanúsító Kft. | May 25, 2024 | |||
| MDD Annex II (excluding section 4) | 144958-19-08-22 | CE Certiso Orvos- és Kórháztechnikai Ellenőrző és Tanúsító Kft. | May 25, 2024 | |||
| MDD Annex II (excluding section 4) | 145068-21-01-21 | CE Certiso Orvos- és Kórháztechnikai Ellenőrző és Tanúsító Kft. | Dec 31, 2028 | |||
| MDD Annex II (excluding section 4) | K-2024/83 | CE Certiso Orvos- és Kórháztechnikai Ellenőrző és Tanúsító Kft. | Dec 31, 2028 |
Market Presence
Devices from this manufacturer are available in 14 countries across Europe.
🇦🇹 Austria
🇧🇪 Belgium
🇧🇬 Bulgaria
🇨🇾 Cyprus
🇨🇿 Czechia
🇩🇪 Germany
🇬🇷 Greece
🇪🇸 Spain
🇫🇷 France
🇮🇹 Italy
🇱🇹 Lithuania
🇵🇱 Poland
🇹🇷 Türkiye
🇬🇧 United Kingdom
Device Portfolio
| Name | ||||
|---|---|---|---|---|
| Embocept S DSM 50 um | EU MDD | Eu Md Class 2b | On Market | 1 |
| SmartGel | EU MDD | Eu Md Class 2b | On Market | 1 |
| SmartPAN | EU MDD | Eu Md Class 2a | On Market | 1 |
| SmartPAN | EU MDD | Eu Md Class 2a | On Market | 1 |