EU Manufacturer
๐ฎ๐น Italy
Active
Tema Sinergie S.p.a.
SRN: IT-MF-000027196
ยท
Via Malpighi 120, 48018 FAENZA (RA), Italy
Basic UDI-DIs
6
Total Devices
8
On Market
8
Off Market
0
Certificates
1
Valid
0
Expiring < 6mo
0
Countries
32
Basic Information
- Address
- Via Malpighi 120, 48018 FAENZA (RA), Italy
- [email protected]
- Phone
- +39 0546 622663
- Website
- www.temasinergie.com
Regulatory Overview
Regulation
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Eu Mdr
4
Eu Mdd
2
Classification
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Eu Md Class 1
4
Eu Md Class 2b
2
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Expired / Withdrawn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) | MED 25033 | KIWA CERMET ITALIA S.P.A. | Dec 15, 2023 |
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 | ||||
|---|---|---|---|---|
| ASTER STAND | EU MDR | Eu Md Class 1 | On Market | 0 |
| KARL STAND | EU MDR | Eu Md Class 1 | On Market | 0 |
| KARL100 2.0 | EU MDR | Eu Md Class 1 | On Market | 0 |
| RAD-INJECT BETA STAND | EU MDR | Eu Md Class 1 | On Market | 0 |
| RAD-INJECT GAMMA STAND | EU MDR | Eu Md Class 1 | On Market | 0 |
| RAD-INJECT GAMMA WALL MOUNT STAND | EU MDR | Eu Md Class 1 | On Market | 0 |
| RAD-INJECT ฮฒ | EU MDD | Eu Md Class 2b | On Market | 1 |
| RAD-INJECT ฮณ | EU MDD | Eu Md Class 2b | On Market | 1 |