EU Manufacturer
๐ฎ๐น Italy
Active
Cometa S.r.l.
SRN: IT-MF-000012630
ยท
Via Gran Sasso 18, 20008 Bareggio, Italy
Basic UDI-DIs
11
Total Devices
12
On Market
12
Off Market
0
Certificates
1
Valid
0
Expiring < 6mo
0
Countries
30
Basic Information
- Address
- Via Gran Sasso 18, 20008 Bareggio, Italy
- [email protected]
- Website
- www.cometasystems.com
Regulatory Overview
Regulation
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Eu Mdr
7
Eu Mdd
4
Classification
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Eu Md Class 1
9
Eu Md Class 2a
2
Device Types
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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Expired / Withdrawn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) | HD 60124595 | TUV Rheinland Italia SRL | Dec 03, 2022 |
Market Presence
Devices from this manufacturer are available in 30 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
๐ฑ๐น Lithuania
๐ฑ๐บ Luxembourg
๐ฑ๐ป Latvia
๐ฒ๐น Malta
๐ณ๐ฑ Netherlands
๐ณ๐ด Norway
๐ต๐ฑ Poland
๐ต๐น Portugal
๐ท๐ด Romania
๐ธ๐ช Sweden
๐ธ๐ฎ Slovenia
๐ธ๐ฐ Slovakia
๐ฌ๐ง United Kingdom
Device Portfolio
| Name | ||||
|---|---|---|---|---|
| Aktos-t | EU MDR | Eu Md Class 1 | On Market | 0 |
| ELECTROMYOGRAPHIC ELECTRODES | EU MDR | Eu Md Class 1 | On Market | 0 |
| EMG AND MOTION TOOLS | EU MDD | Eu Md Class 1 | On Market | 1 |
| Footswitch | EU MDR | Eu Md Class 1 | On Market | 0 |
| InsoleX BT | EU MDR | Eu Md Class 1 | On Market | 0 |
| InsoleX RF | EU MDR | Eu Md Class 1 | On Market | 0 |
| Myon Aktos | EU MDD | Eu Md Class 2a | On Market | 1 |
| Myowise | EU MDD | Eu Md Class 1 | On Market | 0 |
| Myowise | EU MDR | Eu Md Class 1 | On Market | 0 |
| Picoblue | EU MDR | Eu Md Class 1 | On Market | 0 |
| Wave Plus Wireless EMG | EU MDD | Eu Md Class 2a | On Market | 1 |
| WaveTrack | EU MDR | Eu Md Class 1 | On Market | 0 |