Bio3 Implants GmbH
DE-MF-000009538 · Germany · Pforzheim
Bio3 Implants GmbH is registered in the European database on medical devices as a manufacturer, with 358 devices declared. It was not found in the U.S. FDA device establishment register.
What this manufacturer declares
| Class IIa | 221 |
|---|---|
| Class IIb | 137 |
Most frequent device types declared: Dental Implant Advanced, Dental Implant Progressive, Handpiece tools, Implantdrivers tools, Laboratory Analogs.
Among these devices, 38 are declared sterile, 137 implantable.
Devices declared under this manufacturer
- Angled Abutment Pre Molar W 25 degr 10.0mm
- Ball Attachment S 2mm
- Ball Attachment W. 4mm
- Ball Attachment W. 5mm
- Healing Abutment Molar Type S 2.25mm
- Implant Progressive S D 3.3 L 11.5.
- Implant Progressive S D 3.8 L 10.
- Implantdriver Standart Platform 2.1. L 18
- Implantdriver for Hand Piece Standart Platform 2.1. L 18
- Impression Transfer for Aesthetic
- Pin for Template 1.5mm
- Plastic Ring for Ball Attachment
Showing 12 of 358 declared devices.
Catalogue references include BAB5, BAS 2, EAPB25/10.0, GFMS2.25, ITS18, PTI3.3/11.5..
European nomenclature codes declared: P01020180, P01020101.
United States market access
| FDA establishment register | Not found in the FDA register |
|---|---|
| Devices in EUDAMED | 358 |
| 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 | 358 |
|---|---|
| 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. Bio3 Implants GmbH was not found in either the U.S. or the Canadian register.