EU Manufacturer
๐ฎ๐ช Ireland
Active
Aerogen Ltd
SRN: IE-MF-000004597
ยท
Galway Business Park, H91 HE94 Galway, Ireland
Basic UDI-DIs
5
Total Devices
5
On Market
5
Off Market
0
Certificates
1
Valid
0
Expiring < 6mo
0
Countries
25
Basic Information
- Address
- Galway Business Park, H91 HE94 Galway, Ireland
- [email protected]
- Phone
- +353 91 540 400
- Website
- www.aerogen.com
Regulatory Overview
Regulation
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Eu Mdd
5
Classification
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Eu Md Class 2a
5
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Expired / Withdrawn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) | 252.509 | National Standards Authority of Ireland (NSAI) | May 26, 2024 |
Market Presence
Devices from this manufacturer are available in 25 countries across Europe.
๐ฆ๐น Austria
๐ง๐ช Belgium
๐ง๐ฌ Bulgaria
๐จ๐พ Cyprus
๐จ๐ฟ Czechia
๐ฉ๐ช Germany
๐ช๐ช Estonia
๐ฌ๐ท Greece
๐ช๐ธ Spain
๐ซ๐ท France
๐ญ๐ท Croatia
๐ญ๐บ Hungary
๐ฎ๐ช Ireland
๐ฎ๐ธ Iceland
๐ฎ๐น Italy
๐ฑ๐น Lithuania
๐ฑ๐ป Latvia
๐ณ๐ฑ Netherlands
๐ณ๐ด Norway
๐ต๐ฑ Poland
๐ต๐น Portugal
๐ท๐ด Romania
๐ธ๐ช Sweden
๐ธ๐ฎ Slovenia
๐ธ๐ฐ Slovakia
Device Portfolio
| Name | ||||
|---|---|---|---|---|
| Aerogen Solo Adult T-Piece 22mm | EU MDD | Eu Md Class 2a | On Market | 1 |
| Aerogen Solo Nebuliser (10 Pack) | EU MDD | Eu Md Class 2a | On Market | 1 |
| Aerogen USB Controller | EU MDD | Eu Md Class 2a | On Market | 1 |
| Aerogen USB Controller | EU MDD | Eu Md Class 2a | On Market | 1 |
| Aerogen Ultra (10 Pack) | EU MDD | Eu Md Class 2a | On Market | 1 |