EU Manufacturer
๐ฎ๐น Italy
Active
Esaote S.p.A.
SRN: IT-MF-000019024
ยท
Via Enrico Melen 77, 16152 Genova, Italy
Basic UDI-DIs
174
Total Devices
290
On Market
290
Off Market
0
Certificates
2
Valid
0
Expiring < 6mo
0
Countries
32
Basic Information
- Address
- Via Enrico Melen 77, 16152 Genova, Italy
- [email protected]
- Phone
- +3901065471
Regulatory Overview
Regulation
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Eu Mdd
143
Eu Mdr
31
Classification
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Eu Md Class 2a
171
Eu Md Class 1
2
Eu Md Class 3
1
Device Types
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Certificate Health
Total
2
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Expired / Withdrawn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) | G1 095545 0023 | TรV SรD Product Service GmbH | May 25, 2024 | |||
| MDD Annex II (excluding section 4) | G10955450023 | TรV SรD Product Service GmbH | May 26, 2024 |
Market Presence
Devices from this manufacturer are available in 32 countries across Europe.
๐ฆ๐น Austria
๐ง๐ช Belgium
๐ง๐ฌ Bulgaria
๐จ๐พ Cyprus
๐จ๐ฟ Czechia
๐ฉ๐ช Germany
๐ฉ๐ฐ Denmark
๐ช๐ช Estonia
๐ฌ๐ท Greece
๐ช๐ธ Spain
๐ซ๐ฎ Finland
๐ซ๐ท France
๐ญ๐ท Croatia
๐ญ๐บ Hungary
๐ฎ๐ช Ireland
๐ฎ๐ธ Iceland
๐ฎ๐น Italy
๐ฑ๐ฎ Liechtenstein
๐ฑ๐น Lithuania
๐ฑ๐บ Luxembourg
๐ฑ๐ป Latvia
๐ฒ๐น Malta
๐ณ๐ฑ Netherlands
๐ณ๐ด Norway
๐ต๐ฑ Poland
๐ต๐น Portugal
๐ท๐ด Romania
๐ธ๐ช Sweden
๐ธ๐ฎ Slovenia
๐ธ๐ฐ Slovakia
๐น๐ท Tรผrkiye
๐ฌ๐ง United Kingdom
Device Portfolio
| Name | ||||
|---|---|---|---|---|
| MyLabX90 eXP | EU MDR | Eu Md Class 2a | On Market | 0 |
| 2CWLโ | EU MDR | Eu Md Class 2a | On Market | 0 |
| 2CWS | EU MDR | Eu Md Class 2a | On Market | 0 |
| 5CWL | EU MDR | Eu Md Class 2a | On Market | 0 |
| 5CWS | EU MDR | Eu Md Class 2a | On Market | 0 |
| AC2541 | EU MDD | Eu Md Class 2a | On Market | 1 |
| AC2541โ | EU MDR | Eu Md Class 2a | On Market | 0 |
| AC600 | EU MDR | Eu Md Class 2a | On Market | 0 |
| AC750 | EU MDR | Eu Md Class 2a | On Market | 0 |
| AL2442 | EU MDD | Eu Md Class 2a | On Market | 1 |
| AL2445 | EU MDD | Eu Md Class 2a | On Market | 1 |
| AL300 | EU MDR | Eu Md Class 2a | On Market | 0 |
| BC431 | EU MDD | Eu Md Class 2a | On Market | 1 |
| BC441 | EU MDD | Eu Md Class 2a | On Market | 1 |
| BE1123 | EU MDD | Eu Md Class 2a | On Market | 1 |
| BL433 | EU MDR | Eu Md Class 2a | On Market | 0 |
| BL433 | EU MDD | Eu Md Class 2a | On Market | 1 |
| BL433 | EU MDD | Eu Md Class 2a | On Market | 1 |
| C 1-8 | EU MDR | Eu Md Class 2a | On Market | 0 |
| C 1-8 | EU MDD | Eu Md Class 2a | On Market | 1 |
| C 1-8A | EU MDR | Eu Md Class 2a | On Market | 0 |
| C 1-8E | EU MDR | Eu Md Class 2a | On Market | 0 |
| C 2-9 | EU MDR | Eu Md Class 2a | On Market | 0 |
| C 2-9 | EU MDD | Eu Md Class 2a | On Market | 1 |
| CA1123 | EU MDD | Eu Md Class 2a | On Market | 1 |
| CA123 | EU MDD | Eu Md Class 2a | On Market | 1 |
| CA133 | EU MDD | Eu Md Class 2a | On Market | 1 |
| CA421 | EU MDD | Eu Md Class 2a | On Market | 1 |
| CA430E | EU MDR | Eu Md Class 2a | On Market | 0 |
| CA430E | EU MDD | Eu Md Class 2a | On Market | 1 |
| CA431 | EU MDD | Eu Md Class 2a | On Market | 1 |
| CA541 | EU MDR | Eu Md Class 2a | On Market | 0 |
| CA541 | EU MDD | Eu Md Class 2a | On Market | 1 |
| CA621 | EU MDD | Eu Md Class 2a | On Market | 1 |
| CA631 | EU MDD | Eu Md Class 2a | On Market | 1 |
| CERVICAL COIL N.14 | EU MDR | Eu Md Class 1 | On Market | 0 |
| CERVICAL COIL N.9 | EU MDR | Eu Md Class 1 | On Market | 0 |
| CX 1-8 | EU MDR | Eu Md Class 2a | On Market | 0 |
| E 3-12 | EU MDR | Eu Md Class 2a | On Market | 0 |
| E 3-12 | EU MDD | Eu Md Class 2a | On Market | 1 |
| E-MRI Brio Viewer | EU MDD | Eu Md Class 1 | On Market | 0 |
| E-MRI Brio Viewer eXP | EU MDD | Eu Md Class 2a | On Market | 1 |
| E-MRI EVO Viewer | EU MDR | Eu Md Class 2a | On Market | 0 |
| EC1123 | EU MDD | Eu Md Class 2a | On Market | 1 |
| EC123 | EU MDD | Eu Md Class 2a | On Market | 1 |
| EC123 | EU MDD | Eu Md Class 2a | On Market | 1 |
| G-scan Brio | EU MDD | Eu Md Class 2a | On Market | 1 |
| G-scan Brio Premium | EU MDD | Eu Md Class 2a | On Market | 1 |
| G-scan MSK | EU MDR | Eu Md Class 2a | On Market | 0 |
| G-scan Open | EU MDR | Eu Md Class 2a | On Market | 0 |