Delta Med SPA
IT-MF-000027962 · Italy · Viadana
Delta Med SPA is registered in the European database on medical devices as a manufacturer, with 1 442 devices declared. It is also registered as a device establishment with the U.S. FDA.
What this manufacturer declares
| Class IIa | 1 442 |
|---|
Most frequent device types declared: Custom pack for venous access procedures - MDN 1204, Midline Kit, Obturators, Rectal Catheters - containing LATEX, Safety IV Catheters with closed system.
Among these devices, 1 401 are declared sterile, 12 with a measuring function.
Devices declared under this manufacturer
- B-BLOCK PRO 2.0 G16 X 32 PUR R NL
- B-BLOCK PRO 2.0 G20 X 25 PUR R NL
- B-BLOCK.PRO Y G18X25 PUR PNL
- Closia DP 18G 32MM
- DELTA Arterial Cath PUR 22G 25mm
- DELTA MIDLINE 5Frx1Lx25cm-DM07DS
- DELTAVEN 16G 32MM
- DELTAVEN SC 22G 25MM
- Delta Self Safe T 16G 30mm
- Double-lumen rectal catheter for urodynamic examination with latex bal
- Neo Delta Ven T 22G 25mm
- OTT.KLINIJECT 20G
Showing 12 of 1 442 declared devices.
Catalogue references include 03.Q2225.42, 3128522, 335251301022, 3856222, 58044425200560, 58044432160560.
European nomenclature codes declared: C01010103, C0101010102, T020102, C0101010202, T0202, V0599.
United States market access
| FDA establishment register | Registered with FDA |
|---|---|
| Matched entry | DELTAMED GMBH (DE) · FDA 3002789526 |
| Devices in EUDAMED | 1 442 |
| Country of registration | Italy |
Device-level evidence
| Devices with a numeric GTIN | 1 442 |
|---|---|
| Found in the U.S. device database | 6 |
| Share | 0.4 % |
Canadian market access
| Health Canada licence listing | Licensed in Canada |
|---|---|
| Matched entry | DELTAMED GMBH |
What it holds in Canada
| Licences on record | 13 |
|---|---|
| Currently active | 0 |
| Class 2 devices | 4 |
| Class 3 devices | 9 |
| First licensed | 2004-07-14 |
Licence types: Device Family (6), System (3), Device Group Family (2), Single Device (2).
Licensed under: RENAMEL RESIN COMPOSITE RESTORATIVE, INSURE RESIN DENTAL CEMENT, COSMECORE, COSMESEAL, RENAMEL NANO +PLUS LIGHT-CURED DENTAL COMPOSIT, P PRO CROWN & BRIDGE.
North American profile: Both markets. Delta Med SPA is registered in both the United States and Canada.