EU Manufacturer
๐ฎ๐น Italy
Active
DEKA M.E.L.A. SRL
SRN: IT-MF-000007389
ยท
Via Baldanzese 17, 50041 Calenzano (FI), Italy
Basic UDI-DIs
22
Total Devices
83
On Market
83
Off Market
0
Certificates
1
Valid
0
Expiring < 6mo
0
Countries
32
Basic Information
- Address
- Via Baldanzese 17, 50041 Calenzano (FI), Italy
- [email protected]
- Phone
- +39 055 8832884
- Website
- www.dekalaser.com
Regulatory Overview
Regulation
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Eu Mdr
16
Eu Mdd
6
Classification
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Eu Md Class 2b
18
Eu Md Class 2a
3
Eu Md Class 1
1
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Expired / Withdrawn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) | G1 098416 0008 | 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 | ||||
|---|---|---|---|---|
| BODYLAB | EU MDR | Eu Md Class 2a | On Market | 0 |
| CARBON DIOXIDE SURGICAL LASER | EU MDR | Eu Md Class 2b | On Market | 0 |
| Colposcan | EU MDR | Eu Md Class 2b | On Market | 0 |
| Colposcan | EU MDR | Eu Md Class 2b | On Market | 0 |
| DOT PRO | EU MDR | Eu Md Class 2b | On Market | 0 |
| DR Arnold | EU MDR | Eu Md Class 2a | On Market | 0 |
| DermaSCAN | EU MDR | Eu Md Class 2b | On Market | 0 |
| DermaSCAN | EU MDR | Eu Md Class 2b | On Market | 0 |
| EasySpot Hybrid Micromanipulator | EU MDR | Eu Md Class 1 | On Market | 0 |
| EasySpot Micromanipulator | EU MDR | Eu Md Class 1 | On Market | 0 |
| EasySpot Micromanipulator | EU MDR | Eu Md Class 1 | On Market | 0 |
| EndoScan | EU MDR | Eu Md Class 2b | On Market | 0 |
| Excilite ฮผ | EU MDD | Eu Md Class 2b | On Market | 1 |
| Excilite ฮผ | EU MDR | Eu Md Class 2b | On Market | 0 |
| GALILEO | EU MDR | Eu Md Class 2b | On Market | 0 |
| GALILEO | EU MDR | Eu Md Class 2b | On Market | 0 |
| HiScan | EU MDR | Eu Md Class 2b | On Market | 0 |
| HiScan | EU MDR | Eu Md Class 2b | On Market | 0 |
| HiScan DOT | EU MDR | Eu Md Class 2b | On Market | 0 |
| HiScan DOT | EU MDR | Eu Md Class 2b | On Market | 0 |
| HiScan DOT + | EU MDR | Eu Md Class 2b | On Market | 0 |
| HiScan DOT S | EU MDR | Eu Md Class 2b | On Market | 0 |
| HiScan DOT/RF | EU MDR | Eu Md Class 2b | On Market | 0 |
| HiScan SCAR 3 | EU MDR | Eu Md Class 2b | On Market | 0 |
| HiScan SCAR 3 | EU MDR | Eu Md Class 2b | On Market | 0 |
| HiScan SCAR 3 | EU MDR | Eu Md Class 2b | On Market | 0 |
| HiScan Surgical | EU MDR | Eu Md Class 2b | On Market | 0 |
| HiScan Surgical | EU MDR | Eu Md Class 2b | On Market | 0 |
| HiScan Surgical | EU MDR | Eu Md Class 2b | On Market | 0 |
| HiScan V2LR | EU MDR | Eu Md Class 2b | On Market | 0 |
| HiScan V2LR | EU MDR | Eu Md Class 2b | On Market | 0 |
| HiScan V2LR | EU MDR | Eu Md Class 2b | On Market | 0 |
| HiScan V2LR | EU MDR | Eu Md Class 2b | On Market | 0 |
| HiScan V2LR | EU MDR | Eu Md Class 2b | On Market | 0 |
| HiScan V2LR | EU MDR | Eu Md Class 2b | On Market | 0 |
| HiScan V2LR | EU MDR | Eu Md Class 2b | On Market | 0 |
| LIPO AI | EU MDR | Eu Md Class 2b | On Market | 0 |
| LUXEA | EU MDD | Eu Md Class 2b | On Market | 1 |
| MONALISA GLIDE | EU MDR | Eu Md Class 2b | On Market | 0 |
| Monalisa Glide | EU MDR | Eu Md Class 2b | On Market | 0 |
| ProctoScan | EU MDR | Eu Md Class 2b | On Market | 0 |
| SCAR 3 PRO | EU MDR | Eu Md Class 2b | On Market | 0 |
| SCHWARZY | EU MDR | Eu Md Class 2a | On Market | 0 |
| SMARTXIDE | EU MDR | Eu Md Class 2b | On Market | 0 |
| SMARTXIDE TOUCH | EU MDR | Eu Md Class 2b | On Market | 0 |
| Smart US-20 D | EU MDR | Eu Md Class 2b | On Market | 0 |
| SmartXide | EU MDR | Eu Md Class 2b | On Market | 0 |
| SmartXide 50 HS | EU MDR | Eu Md Class 2b | On Market | 0 |
| SmartXide HS | EU MDR | Eu Md Class 2b | On Market | 0 |
| SmartXide HS | EU MDR | Eu Md Class 2b | On Market | 0 |