MEDEALIS GmbH
DE-MF-000019555 · Germany · Abtsteinach
MEDEALIS GmbH is registered in the European database on medical devices as a manufacturer, with 114 devices declared. It is also registered as a device establishment with the U.S. FDA.
What this manufacturer declares
| Class IIa | 78 |
|---|---|
| Class IIb | 36 |
Most frequent device types declared: Accessories for prosthetic restoration, Angled Dental Abutment 18°, Dental Abutment Screw, Instrument, Straight Dental Abutment.
Among these devices, 36 are declared implantable, 5 reusable.
Devices declared under this manufacturer
- CERALOG® PL Docklocs® HPP Extended Pivot Low Retention Replacement Ins
- CERALOG® PL Docklocs® HPP Extended Pivot Medium Retention Replacement
- CERALOG® PL Docklocs® Latch Handpiece Driver, Tri-Lobe (with Abutment
- Clic'n Loc
- Docklocs® Abutment Lab Analog (4mm Diameter) (4 Pack)
- Docklocs® Denture Cap Assembly Zirconia (2 Pack)
- Docklocs® Enhanced Denture Cap Assembly red (4 Pack)
- Docklocs® HPP Extended Pivot Medium Retention Replacement Inserts (Ora
- Docklocs® Impression Coping (4 Pack)
- Docklocs® Processing Insert (Black) (8 Pack)
- NobelPearl™ Docklocs® HPP Extended Pivot High Retention Replacement In
- NobelPearl™ Docklocs® HPP Extended Pivot Medium Retention Replacement
Showing 12 of 114 declared devices.
Catalogue references include 970817, A0014.SZT.CL, A0015.SZT.CL, A0023.CL, A0144.CL, HP2253.2001.
European nomenclature codes declared: P01020180, Q010207, Q010280, L26, L091001, P01020101.
United States market access
| FDA establishment register | Registered with FDA |
|---|---|
| Matched entry | MEDEALIS GMBH (DE) · FDA 3017064961 |
| Devices in EUDAMED | 114 |
| Country of registration | Germany |
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: United States only. MEDEALIS GmbH is registered in the United States but was not found in the Canadian register.