Delmont imaging
FR-MF-000000157 · France · La Ciotat
Delmont imaging is registered in the European database on medical devices as a manufacturer, with 11 devices declared. It was not found in the U.S. FDA device establishment register.
What this manufacturer declares
| Class IIa | 11 |
|---|
Most frequent device types declared: ICE.
Among these devices, 1 are declared sterile, 2 reusable, 4 active.
Devices declared under this manufacturer
- HD hysteroscope 2,9mm 30° 300mm autoclavable
- ICE
- Mangeshikar handle with Pozzi forceps rotation module
- Manual irrigation cuff for 1L liquid bag
- Manual irrigation cuff for 3L liquid bag
- Manual irrigation cuff for 500mL liquid bag
- Sterilization basket for two instruments
- iCare SLIDE. Camera control unit only
- iCare camera head without coupler
- iCare without SLIDE. Camera control unit only.
Catalogue references include D100 100 000, D100 110 000, D100 300 000, D110 100 023, D110 100 024, D110 100 025.
European nomenclature codes declared: A99, Z12020403, S010401, Z12020401,Z12020402, Z12020703, Z12020704.
United States market access
| FDA establishment register | Not found in the FDA register |
|---|---|
| Devices in EUDAMED | 11 |
| 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 | 11 |
|---|---|
| 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. Delmont imaging was not found in either the U.S. or the Canadian register.
Notified body certificates
| Certificate | Status | Expiry |
|---|---|---|
MDR-0032 | issued | 2030-10-16 |
MDR-0021 | supplemented | 2029-11-07 |