Coltène/Whaledent GmbH + Co. KG
DE-MF-000005717 · Germany · Langenau
Coltène/Whaledent GmbH + Co. KG is registered in the European database on medical devices as a manufacturer, with 148 devices declared. It was not found in the U.S. FDA device establishment register.
What this manufacturer declares
| Class IIa | 148 |
|---|
Most frequent device types declared: Articulating paper, Comprecap Set, Cotton Pellets, Dental Rolls, GuttaFlow Sealer.
Among these devices, 1 are declared sterile, 4 implantable.
Devices declared under this manufacturer
- Adaco, 12 Steel Separating Strips, double-sided, 4 mm, F-40 µm
- Adaco, 12 Steel Separating Strips, onesided, 8 mm, M-50 µm
- Alpen 12 Steel Separating Strips, onesided, 8 mm, 50 µm
- HANEL Articulating paper 80µ C-shaped blue-red
- HANEL OccluFoil+ 12µ 22mm 1sided green PET
- HANEL OccluFoil+ 12µ 22mm 2sided red PET
- HANEL Occlusion foil 12µ 22mm 2sided red
- roeko Comprecap anatomic Set, 120 pcs
- roeko GuttaFlow2 Refill Applicator
- roeko GuttaFlow2 Standard Set
- roeko Retracto / braided / non-impregnated, fine (1), 225 cm
- roeko Retracto / twisted / non-impregnated, x-fine (0), 225 cm
Showing 12 of 148 declared devices.
Catalogue references include 223112, 252002, 480042, 480374, 523000, 531299.
European nomenclature codes declared: Q0199, Q019004, Q01010403, Q01020299, Q01020201, Q010204.
United States market access
| FDA establishment register | Not found in the FDA register |
|---|---|
| Devices in EUDAMED | 148 |
| Country of registration | Germany |
⚠️ Not found is not the same as not sold — how this comparison can be wrong.
Device-level evidence
| Devices with a numeric GTIN | 67 |
|---|---|
| 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. Coltène/Whaledent GmbH + Co. KG was not found in either the U.S. or the Canadian register.