EUDAMED update: Oct 22, 2025

Bio3 Implants GmbH

DE-MF-000009538

Active358 devices

Address: Hanauer Str, 1-5 75181 Pforzheim
Role: Manufacturer
Date of registration: Jul 12, 2021
Country: Germany

Bio3 Implants GmbH is a medical device manufacturer registered in EUDAMED. The company has 358 devices on the EU market across 12 countries. Headquartered in Pforzheim, Germany. Explore the regulatory profile, devices and certificates on MD Atlas.

About Bio3 Implants GmbH

: DE-MF-000009538
Role: Manufacturer
Country: Germany
Organization name: Bio3 Implants GmbH
EU VAT number: DE 295433974
EORI: DE 872726342538825
Trade register: HBR 731453
Date of registration: Jul 12, 2021

Contact details for Bio3 Implants GmbH

Phone: 017678531156
Email: alla.prokosheva@bio3-implants.com
Website: https://bio3-implants.com
Address: 1-5, HANAUER STR 75181 PFORZHEIM GERMANY

Competent authority

Name: DE/CA38 - Regierungspräsidium Karlsruhe

Phone: -
Email: medizinprodukte@rpk.bwl.de

Officers and regulatory representatives of Bio3 Implants GmbH

PROKOSHEVA Alla
- Checking the conformity of the devices in accordance with the quality management system (QMS) before release; - Preparing and maintaining the technical documentation and EU Declaration of Conformity - Meeting post-market surveillance obligations; - Vigilance reporting and analysis requirements are met, including serious incidents, field safety corrective actions and report trending; and - For investigational devices a signed statement that the device meets the GSPRs.
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Product	Trade name	Reference / catalog number	Primary DI The Primary DI is the main UDI-DI a manufacturer designates as the principal identifier for a device in EUDAMED. View in glossary →	Quantity	Status
Abutment Canine Type S. 10.5mm	Abutment Canine Type S. 10.5mm	`GACS10.5`	`04060475000000`	1	On the market
Abutment Canine Type S. 9.0mm	Abutment Canine Type S. 9.0mm	`GACS9.0`	`04060475000017`	1	On the market
Abutment Canine Type W. 10.5mm	Abutment Canine Type W. 10.5mm	`GACB10.5`	`04060475000024`	1	On the market
Abutment Canine Type W. 9.0mm	Abutment Canine Type W. 9.0mm	`GACB9.0`	`04060475000031`	1	On the market
Abutment Incisor Type S. 10.0mm	Abutment Incisor Type S. 10.0mm	`GAIS10.0`	`04060475000048`	1	On the market
Abutment Incisor Type S. 8.5mm	Abutment Incisor Type S. 8.5mm	`GAIS8.5`	`04060475000055`	1	On the market
Abutment Incisor Type W. 10.0mm	Abutment Incisor Type W. 10.0mm	`GAIB10.0`	`04060475000062`	1	On the market
Abutment Incisor Type W. 8.5mm	Abutment Incisor Type W. 8.5mm	`GAIB8.5`	`04060475000079`	1	On the market
Abutment Molar Type S. 7.5mm	Abutment Molar Type S. 7.5mm	`GAMS7.5`	`04060475000086`	1	On the market
Abutment Molar Type S. 8.5mm	Abutment Molar Type S. 8.5mm	`GAMS8.5`	`04060475000093`	1	On the market
Abutment Molar Type W. 7.5mm	Abutment Molar Type W. 7.5mm	`GAMB7.5`	`04060475000109`	1	On the market
Abutment Molar Type W. 8.5mm	Abutment Molar Type W. 8.5mm	`GAMB8.5`	`04060475000116`	1	On the market
Abutment Pre Molar Type S. 10.5mm	Abutment Pre Molar Type S. 10.5mm	`GAPS10.5`	`04060475000123`	1	On the market
Abutment Pre Molar Type S. 9.0mm	Abutment Pre Molar Type S. 9.0mm	`GAPS9.0`	`04060475000130`	1	On the market
Abutment Pre Molar Type W. 10.5mm	Abutment Pre Molar Type W. 10.5mm	`GAPB10.5`	`04060475000147`	1	On the market
Abutment Pre Molar Type W. 9.0mm	Abutment Pre Molar Type W. 9.0mm	`GAPB9.0`	`04060475000154`	1	On the market
Adaptor for Handpiece	Adaptor for Handpiece	`AD`	`04060475001380`	1	On the market
Adaptor for Ratchet	Adaptor for Ratchet	`AR`	`04060475002349`	1	On the market
Analog for Ball Attachment	Analog for Ball Attachment	`ABA`	`04060475005524`	1	On the market
Analog for locators	Analog for locators	`ALC`	`04060475005531`	1	On the market
Analog Implant Laboratory for Aesthetic S	Analog Implant Laboratory for Aesthetic S	`IAES`	`04060475003087`	1	On the market
Angled abutment canine S 15 deg 9 mm	Angled abutment canine S 15 deg 9 mm	`EACS15/9.0`	`04060475000178`	1	On the market
Angled abutment canine S 15 degr 10.0mm	Angled abutment canine S 15 degr 10.0mm	`EACS15/10.0`	`04060475000185`	1	On the market
Angled abutment canine S 25 degr 10.0mm	Angled abutment canine S 25 degr 10.0mm	`EACS25/10.0`	`04060475000192`	1	On the market
Angled abutment canine S 25 degr 9.0mm	Angled abutment canine S 25 degr 9.0mm	`EACS25/9.0`	`04060475000208`	1	On the market

Product	Trade name	Reference / catalog number	Primary DI The Primary DI is the main UDI-DI a manufacturer designates as the principal identifier for a device in EUDAMED. View in glossary →	Quantity	Status
Abutment Canine Type S. 10.5mm	Abutment Canine Type S. 10.5mm	`GACS10.5`	`04060475000000`	1	On the market
Abutment Canine Type S. 9.0mm	Abutment Canine Type S. 9.0mm	`GACS9.0`	`04060475000017`	1	On the market
Abutment Canine Type W. 10.5mm	Abutment Canine Type W. 10.5mm	`GACB10.5`	`04060475000024`	1	On the market
Abutment Canine Type W. 9.0mm	Abutment Canine Type W. 9.0mm	`GACB9.0`	`04060475000031`	1	On the market
Abutment Incisor Type S. 10.0mm	Abutment Incisor Type S. 10.0mm	`GAIS10.0`	`04060475000048`	1	On the market
Abutment Incisor Type S. 8.5mm	Abutment Incisor Type S. 8.5mm	`GAIS8.5`	`04060475000055`	1	On the market
Abutment Incisor Type W. 10.0mm	Abutment Incisor Type W. 10.0mm	`GAIB10.0`	`04060475000062`	1	On the market
Abutment Incisor Type W. 8.5mm	Abutment Incisor Type W. 8.5mm	`GAIB8.5`	`04060475000079`	1	On the market
Abutment Molar Type S. 7.5mm	Abutment Molar Type S. 7.5mm	`GAMS7.5`	`04060475000086`	1	On the market
Abutment Molar Type S. 8.5mm	Abutment Molar Type S. 8.5mm	`GAMS8.5`	`04060475000093`	1	On the market
Abutment Molar Type W. 7.5mm	Abutment Molar Type W. 7.5mm	`GAMB7.5`	`04060475000109`	1	On the market
Abutment Molar Type W. 8.5mm	Abutment Molar Type W. 8.5mm	`GAMB8.5`	`04060475000116`	1	On the market
Abutment Pre Molar Type S. 10.5mm	Abutment Pre Molar Type S. 10.5mm	`GAPS10.5`	`04060475000123`	1	On the market
Abutment Pre Molar Type S. 9.0mm	Abutment Pre Molar Type S. 9.0mm	`GAPS9.0`	`04060475000130`	1	On the market
Abutment Pre Molar Type W. 10.5mm	Abutment Pre Molar Type W. 10.5mm	`GAPB10.5`	`04060475000147`	1	On the market
Abutment Pre Molar Type W. 9.0mm	Abutment Pre Molar Type W. 9.0mm	`GAPB9.0`	`04060475000154`	1	On the market
Adaptor for Handpiece	Adaptor for Handpiece	`AD`	`04060475001380`	1	On the market
Adaptor for Ratchet	Adaptor for Ratchet	`AR`	`04060475002349`	1	On the market
Analog for Ball Attachment	Analog for Ball Attachment	`ABA`	`04060475005524`	1	On the market
Analog for locators	Analog for locators	`ALC`	`04060475005531`	1	On the market
Analog Implant Laboratory for Aesthetic S	Analog Implant Laboratory for Aesthetic S	`IAES`	`04060475003087`	1	On the market
Angled abutment canine S 15 deg 9 mm	Angled abutment canine S 15 deg 9 mm	`EACS15/9.0`	`04060475000178`	1	On the market
Angled abutment canine S 15 degr 10.0mm	Angled abutment canine S 15 degr 10.0mm	`EACS15/10.0`	`04060475000185`	1	On the market
Angled abutment canine S 25 degr 10.0mm	Angled abutment canine S 25 degr 10.0mm	`EACS25/10.0`	`04060475000192`	1	On the market
Angled abutment canine S 25 degr 9.0mm	Angled abutment canine S 25 degr 9.0mm	`EACS25/9.0`	`04060475000208`	1	On the market

Bio3 Implants GmbH

About Bio3 Implants GmbH

Contact details for Bio3 Implants GmbH

Competent authority

Officers and regulatory representatives of Bio3 Implants GmbH

Export the 358 devices of Bio3 Implants GmbH

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About Bio3 Implants GmbH

Contact details for Bio3 Implants GmbH

Competent authority

Officers and regulatory representatives of Bio3 Implants GmbH

Statistics for Bio3 Implants GmbH

Certificate health for Bio3 Implants GmbH

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Devices by risk class

Device catalog for Bio3 Implants GmbH

Device families (Basic UDI-DI) of Bio3 Implants GmbH

Market presence of Bio3 Implants GmbH

Export the 358 devices of Bio3 Implants GmbH

Related searches

Market presence of Bio3 Implants GmbH

Devices by risk class

Certificate health for Bio3 Implants GmbH

Statistics for Bio3 Implants GmbH

Related documents

Device catalog for Bio3 Implants GmbH

Device families (Basic UDI-DI) of Bio3 Implants GmbH