EU Manufacturer
๐ฎ๐น Italy
Active
GEM SRL
SRN: IT-MF-000012892
ยท
VIA DEI CAMPI 2, 55049 VIAREGGIO, Italy
Basic UDI-DIs
28
Total Devices
38
On Market
38
Off Market
0
Certificates
6
Valid
1
Expiring < 6mo
0
Countries
32
Basic Information
- Address
- VIA DEI CAMPI 2, 55049 VIAREGGIO, Italy
- [email protected]
- Phone
- +39 0584 391388/389784
- Website
- www.gemitaly.it
Regulatory Overview
Regulation
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Eu Mdd
22
Eu Mdr
6
Classification
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Eu Md Class 2a
22
Eu Md Class 3
6
Device Types
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Certificate Health
Total
6
Valid
1
Expiring < 6mo
0
Expired / Withdrawn
5
Certificates by Expiry Year
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| Type | Number | Expiry Date | Status | |||
|---|---|---|---|---|---|---|
| MDD Annex V | DD 60135036 | TUV Rheinland Italia SRL | Dec 13, 2023 | |||
| MDD Annex V | QPZ-1920-19 | ISTITUTO SUPERIORE DI SANITA' | May 26, 2024 | |||
| MDD Annex II Section 4 | EPG-0242-19 | ISTITUTO SUPERIORE DI SANITA' | May 26, 2024 | |||
| MDD Annex II Section 4 | QCT-0133-19 | ISTITUTO SUPERIORE DI SANITA' | May 26, 2024 | |||
| MDD Annex II Section 4 | EPG0242-19 | ISTITUTO SUPERIORE DI SANITA' | May 26, 2024 | |||
| MDR QA | ITD 1450390 1 | TUV Rheinland Italia SRL | MDR | Nov 2023 | Nov 14, 2028 | Supplemented |
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 | ||||
|---|---|---|---|---|
| CATETERE LAPAROSCOPICO | EU MDR | Eu Md Class 2a | On Market | 0 |
| CATETERE FLESSIBILE | EU MDD | Eu Md Class 2a | On Market | 1 |
| CATETERE RIGIDO | EU MDD | Eu Md Class 2a | On Market | 1 |
| CATETERE RIGIDO LAPAROSCOPICO | EU MDR | Eu Md Class 2a | On Market | 0 |
| DISPENSING TIP | EU MDR | Eu Md Class 2a | On Market | 0 |
| DROP CONTROL DEVICE | EU MDR | Eu Md Class 2a | On Market | 0 |
| Dispensing Tip | EU MDD | Eu Md Class 2a | On Market | 1 |
| Drop control device | EU MDD | Eu Md Class 2a | On Market | 1 |
| GLUBRAN 2 | EU MDD | Eu Md Class 3 | On Market | 2 |
| GLUBRAN 2 | EU MDD | Eu Md Class 3 | On Market | 2 |
| GLUBRAN 2 | EU MDD | Eu Md Class 3 | On Market | 2 |
| GLUBRAN 2 | EU MDD | Eu Md Class 3 | On Market | 2 |
| GLUBRAN 2 | EU MDD | Eu Md Class 3 | On Market | 2 |
| GLUBRAN 2 | EU MDD | Eu Md Class 3 | On Market | 2 |
| GLUBRAN TISS 2 | EU MDR | Eu Md Class 2a | On Market | 0 |
| GLUBRAN TISS 2 | EU MDR | Eu Md Class 2a | On Market | 0 |
| GLUBRAN TISS 2 | EU MDR | Eu Md Class 2a | On Market | 0 |
| GLUBRAN TISS2 | EU MDD | Eu Md Class 2a | On Market | 1 |
| GLUBRAN TISS2 | EU MDD | Eu Md Class 2a | On Market | 1 |
| GLUBRAN TISS2 | EU MDD | Eu Md Class 2a | On Market | 1 |
| GLUTACK | EU MDR | Eu Md Class 2a | On Market | 0 |
| GLUTACK | EU MDD | Eu Md Class 2a | On Market | 1 |
| GLUTACK | EU MDD | Eu Md Class 2a | On Market | 1 |
| GLUTACK | EU MDR | Eu Md Class 2a | On Market | 0 |
| GLUTACK SHORT | EU MDR | Eu Md Class 2a | On Market | 0 |
| GLUTACK SHORT | EU MDR | Eu Md Class 2a | On Market | 0 |
| GLUTACK SHORT | EU MDD | Eu Md Class 2a | On Market | 1 |
| GLUTACK SHORT | EU MDD | Eu Md Class 2a | On Market | 1 |
| NEBULIZZATORE CORTO PER COLLA CHIRURGICA GLUBRAN 2 | EU MDD | Eu Md Class 2a | On Market | 1 |
| NEBULIZZATORE CORTO SMALL PER COLLA CHIRURGICA GLUBRAN 2 | EU MDD | Eu Md Class 2a | On Market | 1 |
| NEBULIZZATORE PER COLLA CHIRURGICA GLUBRAN 2 | EU MDD | Eu Md Class 2a | On Market | 1 |
| NEBULIZZATORE PER COLLA CHIRURGICA GLUBRAN 2 SMALL | EU MDD | Eu Md Class 2a | On Market | 1 |
| NEBULIZZATORE RIGIDO PER COLLA CHIRURGICA GLUBRAN 2 | EU MDD | Eu Md Class 2a | On Market | 1 |
| Nebulizzatore Corto SMALL per colla chirurgica Glubran 2 | EU MDR | Eu Md Class 2a | On Market | 0 |
| Nebulizzatore Corto per Colla Chirurgica Glubran 2 | EU MDR | Eu Md Class 2a | On Market | 0 |
| Nebulizzatore Rigido per Colla Chirurgica Glubran 2 | EU MDR | Eu Md Class 2a | On Market | 0 |
| Nebulizzatore per Colla Chirurgica Glubran 2 SMALL | EU MDR | Eu Md Class 2a | On Market | 0 |
| Nebulizzatore per colla chirurgica Glubran 2 | EU MDR | Eu Md Class 2a | On Market | 0 |