EU Manufacturer
🇺🇸 United States
Active
Adagio Medical, Inc.
SRN: US-MF-000001129
·
Merit Circle 26051, 92653 Laguna Hills, United States
Basic UDI-DIs
25
Total Devices
25
On Market
25
Off Market
0
Certificates
3
Valid
0
Expiring < 6mo
0
Countries
5
Basic Information
- Address
- Merit Circle 26051, 92653 Laguna Hills, United States
- [email protected]
- Phone
- +1 949 348 1188
- Website
- adagiomedical.com
Regulatory Overview
Regulation
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Eu Mdd
25
Classification
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Eu Md Class 1
23
Eu Md Class 2a
1
Eu Md Class 3
1
Certificate Health
Total
3
Valid
0
Expiring < 6mo
0
Expired / Withdrawn
3
Certificates by Expiry Year
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| Type | Number | Expiry Date | Status | |||
|---|---|---|---|---|---|---|
| MDD Annex II (excluding section 4) | G1S 103403 0004 | TÜV SÜD Product Service GmbH | May 26, 2024 | |||
| MDD Annex II Section 4 | G7 103403 0005 | TÜV SÜD Product Service GmbH | May 26, 2024 | |||
| MDD Annex II (excluding section 4) | G1 103403 0002 | TÜV SÜD Product Service GmbH | May 26, 2024 |
Market Presence
Devices from this manufacturer are available in 5 countries across Europe.
🇧🇪 Belgium
🇩🇪 Germany
🇮🇪 Ireland
🇳🇱 Netherlands
🇬🇧 United Kingdom
Device Portfolio
| Name | ||||
|---|---|---|---|---|
| Adagio iCLAS™ Shaped Stylets | EU MDD | Eu Md Class 1 | On Market | 1 |
| Esophageal Warming Balloon Catheter | EU MDD | Eu Md Class 2a | On Market | 1 |
| iCLAS™ Cryoablation Catheter | EU MDD | Eu Md Class 3 | On Market | 2 |
| iCLAS™ Shaped Stylet Accesory | EU MDD | Eu Md Class 1 | On Market | 1 |
| iCLAS™ Shaped Stylet Accesory | EU MDD | Eu Md Class 1 | On Market | 1 |
| iCLAS™ Shaped Stylet Accesory | EU MDD | Eu Md Class 1 | On Market | 1 |
| iCLAS™ Shaped Stylet Accesory | EU MDD | Eu Md Class 1 | On Market | 1 |
| iCLAS™ Shaped Stylet Accesory | EU MDD | Eu Md Class 1 | On Market | 1 |
| iCLAS™ Shaped Stylet Accesory | EU MDD | Eu Md Class 1 | On Market | 1 |
| iCLAS™ Shaped Stylet Accesory | EU MDD | Eu Md Class 1 | On Market | 1 |
| iCLAS™ Shaped Stylet Accesory | EU MDD | Eu Md Class 1 | On Market | 1 |
| iCLAS™ Shaped Stylet Accesory | EU MDD | Eu Md Class 1 | On Market | 1 |
| iCLAS™ Shaped Stylet Accesory | EU MDD | Eu Md Class 1 | On Market | 1 |
| iCLAS™ Shaped Stylet Accesory | EU MDD | Eu Md Class 1 | On Market | 1 |
| iCLAS™ Shaped Stylet Accesory | EU MDD | Eu Md Class 1 | On Market | 1 |
| iCLAS™ Shaped Stylet Accesory | EU MDD | Eu Md Class 1 | On Market | 1 |
| iCLAS™ Shaped Stylet Accesory | EU MDD | Eu Md Class 1 | On Market | 1 |
| iCLAS™ Shaped Stylet Accesory | EU MDD | Eu Md Class 1 | On Market | 1 |
| iCLAS™ Shaped Stylet Accesory | EU MDD | Eu Md Class 1 | On Market | 1 |
| iCLAS™ Shaped Stylet Accesory | EU MDD | Eu Md Class 1 | On Market | 1 |
| iCLAS™ Shaped Stylet Accesory | EU MDD | Eu Md Class 1 | On Market | 1 |
| iCLAS™ Shaped Stylet Accesory | EU MDD | Eu Md Class 1 | On Market | 1 |
| iCLAS™ Shaped Stylet Accesory | EU MDD | Eu Md Class 1 | On Market | 1 |
| iCLAS™ Shaped Stylet Accesory | EU MDD | Eu Md Class 1 | On Market | 1 |
| iCLAS™ Shaped Stylet Accesory | EU MDD | Eu Md Class 1 | On Market | 1 |