Global D
FR-MF-000024267 · France · BRIGNAIS
Global D is registered in the European database on medical devices as a manufacturer, with 323 devices declared. It was not found in the U.S. FDA device establishment register.
What this manufacturer declares
| Class IIa | 79 |
|---|---|
| Class IIb | 244 |
Most frequent device types declared: Class I CMF and/or Orthodontic and/or Dental instruments for Assembly/, In-Kone® pre-milled blanks/In-Kone® temporary titanium bases/In-Kone® .
Among these devices, 43 are declared sterile, 244 implantable, 19 reusable.
Devices declared under this manufacturer
- 2-Ex implant base + screw
- Abutment + screw
- Cross-drive screwdriver shaft
- Dental implant system
- Drill bit Ø2 mm stop at 15 mm
- Hexa-drive screwdriver shaft Ø≥2 mm
- Intermaxillary fixation screw Ø2 x 7 mm
- MUA ST conical abutment + screw
- Manual bell wrench 3 mm
- Pre-milled + screw
- Screw Ø2 x 7 mm neck 1.5 mm
- Temporary implant base + screw
Showing 12 of 323 declared devices.
Catalogue references include ACCM3MR, ALT2H, CAFO2.0B15, DEVWDR6.5H1.5, DFMEVLC3.3-15H, DPEVLK3.3-12.
European nomenclature codes declared: P01020180, Q010499, L091001, L091099, P01020101, L091002.
United States market access
| FDA establishment register | Not found in the FDA register |
|---|---|
| Devices in EUDAMED | 323 |
| Country of registration | France |
⚠️ Not found is not the same as not sold — how this comparison can be wrong.
Device-level evidence
| Devices with a numeric GTIN | 323 |
|---|---|
| Found in the U.S. device database | 0 |
| Share | 0.0 % |
Canadian market access
| Health Canada licence listing | Not found in the Canadian register |
|---|
⚠️ Canada lists no Class I devices at all — what that excludes.
North American profile: Neither register. Global D was not found in either the U.S. or the Canadian register.
Notified body certificates
| Certificate | Status | Expiry |
|---|---|---|
MDR 00114-A | issued | 2030-12-02 |