GEM SRL
IT-MF-000012892 · Italy · VIAREGGIO
GEM SRL is registered in the European database on medical devices as a manufacturer, with 53 devices declared. It was not found in the U.S. FDA device establishment register.
What this manufacturer declares
| Class IIa | 34 |
|---|---|
| Class I | 19 |
Most frequent device types declared: G-NB-2;G-NB2-75;G-NB2-60; G-NB2-50; G-NB2-35 ;G-NB2S-25, G-NB2-35, G-NBOC2, G-NBOC2-35, G2-NBT.
Among these devices, 53 are declared sterile, 19 implantable.
Devices declared under this manufacturer
- CATETERE LAPAROSCOPICO
- Drop control device
- GLUBRAN 2
- GLUBRAN TISS 2
- GLUBRAN TISS2
- GLUTACK
- GLUTACK SHORT
- NEBULIZZATORE PER COLLA CHIRURGICA GLUBRAN 2
- NEBULIZZATORE PER COLLA CHIRURGICA GLUBRAN 2 SMALL
- NEBULIZZATORE RIGIDO PER COLLA CHIRURGICA GLUBRAN 2
- Nebulizzatore Corto SMALL per colla chirurgica Glubran 2
- Nebulizzatore Corto per Colla Chirurgica Glubran 2
Showing 12 of 53 declared devices.
Catalogue references include G-NB2-35, G-NBOC2, G-NBOC2-35, G2-NBT, G2-NBT-RIG, GB-DS 30.
European nomenclature codes declared: H90010102, M9002, K0180, C900180, V9099, A020102020102.
United States market access
| FDA establishment register | Not found in the FDA register |
|---|---|
| Devices in EUDAMED | 53 |
| Country of registration | Italy |
⚠️ Not found is not the same as not sold — how this comparison can be wrong.
Device-level evidence
| Devices with a numeric GTIN | 31 |
|---|---|
| Found in the U.S. device database | 0 |
| Share | 0.0 % |
Canadian market access
| Health Canada licence listing | Licensed in Canada |
|---|---|
| Matched entry | GEM SRL |
What it holds in Canada
| Licences on record | 8 |
|---|---|
| Currently active | 0 |
| Class 2 devices | 7 |
| Class 4 devices | 1 |
| First licensed | 2011-05-31 |
Licence types: Device Family (5), Single Device (2), Device Group (1).
Licensed under: GLUBRAN 2 SURGICAL GLUE, SPRAY DEVICE FOR SURGICAL GLUE GLUBRAN 2, GLUBRAN TISS, DISPENSING TIP, LAPAROSCOPY CATHETER, DROP CONTROL DEVICE.
North American profile: Canada only. GEM SRL holds a Canadian licence but was not found in the U.S. register.
Notified body certificates
| Certificate | Status | Expiry |
|---|---|---|
ITD 1450390 1 | supplemented | 2028-11-14 |
CVD0027240225 | supplemented | 2029-05-15 |
CSQ0019240225 | supplemented | 2029-05-15 |
295/MDR | issued | 2031-06-03 |
0425-MDR-030094-00 | issued | 2029-09-11 |