EU Manufacturer
๐บ๐ธ United States
Active
Paragonix Technologies, Inc.
SRN: US-MF-000038585
ยท
Winter Street, North 950, 02451 Waltham, United States
Basic UDI-DIs
5
Total Devices
13
On Market
13
Off Market
0
Certificates
0
Valid
0
Expiring < 6mo
0
Countries
19
Basic Information
- Address
- Winter Street, North 950, 02451 Waltham, United States
- [email protected]
- Phone
- (781) 428-4153
Regulatory Overview
Regulation
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Eu Mdr
5
Classification
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Eu Md Class 2a
5
Certificate Health
No certificates registered for this manufacturer.
Market Presence
Devices from this manufacturer are available in 19 countries across Europe.
๐ฆ๐น Austria
๐ง๐ช Belgium
๐จ๐ฟ Czechia
๐ฉ๐ช Germany
๐ฉ๐ฐ Denmark
๐ช๐ธ Spain
๐ซ๐ฎ Finland
๐ซ๐ท France
๐ญ๐ท Croatia
๐ญ๐บ Hungary
๐ฎ๐น Italy
๐ฑ๐ฎ Liechtenstein
๐ฑ๐บ Luxembourg
๐ณ๐ฑ Netherlands
๐ณ๐ด Norway
๐ต๐น Portugal
๐ธ๐ช Sweden
๐ธ๐ฎ Slovenia
๐ธ๐ฐ Slovakia
Device Portfolio
| Name | ||||
|---|---|---|---|---|
| BAROguard Donor Lung Preservation System | EU MDR | Eu Md Class 2a | On Market | 0 |
| BAROguard Donor Lung Preservation System | EU MDR | Eu Md Class 2a | On Market | 0 |
| BAROguard Donor Lung Preservation System | EU MDR | Eu Md Class 2a | On Market | 0 |
| LIVERguard Donor Liver Preservation System | EU MDR | Eu Md Class 2a | On Market | 0 |
| LIVERguard Donor Liver Preservation System | EU MDR | Eu Md Class 2a | On Market | 0 |
| LUNGguard Donor Lung Preservation System | EU MDR | Eu Md Class 2a | On Market | 0 |
| LUNGguard Donor Lung Preservation System | EU MDR | Eu Md Class 2a | On Market | 0 |
| PancreasPak Organ Preservation System | EU MDR | Eu Md Class 2a | On Market | 0 |
| PancreasPak Organ Preservation System | EU MDR | Eu Md Class 2a | On Market | 0 |
| PancreasPak Organ Preservation System | EU MDR | Eu Md Class 2a | On Market | 0 |
| SherpaPak Cardiac Transport System (CTS) | EU MDR | Eu Md Class 2a | On Market | 0 |
| SherpaPak Cardiac Transport System (CTS) | EU MDR | Eu Md Class 2a | On Market | 0 |
| SherpaPak Cardiac Transport System (CTS) | EU MDR | Eu Md Class 2a | On Market | 0 |