Deltamed GmbH
DE-MF-000007882 · Germany · Friedberg
Deltamed GmbH is registered in the European database on medical devices as a manufacturer, with 424 devices declared. It is also registered as a device establishment with the U.S. FDA.
What this manufacturer declares
| Class IIa | 424 |
|---|
Most frequent device types declared: Dental Composites and Accessories - Dental composites => Hybrid filled, Dental Composites and Accessories - Dental composites => Microfilled C, Dental Crown and Bridge Materials and Accessories - Composite Paste, F, Denture Resins and Accessories - Bonding Resin for Denture Resins, Denture Resins and Accessories - Light Curing Denture Resins - Gels.
Among these devices, 369 are declared implantable.
Devices declared under this manufacturer
- Creative Color® Opaquer A2-A2.5
- Creative Color® Opaquer C2-C3
- Deltaform Set
- PRO Resins Base X pink-opaque
- Renamel® Flowable Microfill Body A2.5
- Renamel® Flowable Microfill Body C1
- Renamel® Microfill Enamel Body D2
- Renamel® Microfill Enamel Medium Incisal
- Renamel® Microhybrid Body A1
- Renamel® Microhybrid Body A2
- Renamel® Microhybrid Body C3
- Renamel® Microhybrid Body C4
Showing 12 of 424 declared devices.
Catalogue references include 019.3326, 6031A2, 6031C2, 6061A1, 6061A2, 6073D2.
European nomenclature codes declared: Q01010103, Q0102050199, Q010699, Q01010103,Q0102050199,Q01020601,Q01020602,Q01020605, Q01020601,Q01020602,Q01020605, Q010280.
United States market access
| FDA establishment register | Registered with FDA |
|---|---|
| Matched entry | DELTAMED GMBH (DE) · FDA 3002789526 |
| Devices in EUDAMED | 424 |
| Country of registration | Germany |
Device-level evidence
| Devices with a numeric GTIN | 37 |
|---|---|
| Found in the U.S. device database | 28 |
| Share | 75.7 % |
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. Deltamed GmbH is registered in both the United States and Canada.