Registered with FDA

VITALITEC INTERNATIONAL Medizintechnik GmbH

BALGHEIM, Germany. Lists 1 dental device type with FDA across 1 registered establishment.

FDA owner/operator9005335Repacker / relabeler

Device types listed: 1
Brands and models: 1
510(k) clearances: 0as applicant
Markets registered in: 32 registrations outside the US
Establishments: 1Germany

Registered in 3 markets

Where regulators' registries name VITALITEC INTERNATIONAL Medizintechnik GmbH as the manufacturer or the registration holder of a device.

All markets

RegisteredHome: GermanyOne marker per market

Market	Regulator	Named as	Name on the registry	Registrations	Issued	Records
United States	FDA	Lister	VITALITEC INTERNATIONAL Medizintechnik GmbH	1 device types	—	Below
Brazil	ANVISA	Manufacturer	VITALITEC INTERNATIONAL MEDIZINTECHNIK GMBH	1	2017–2017	Pure Global AI
Serbia	ALIMS	Manufacturer	VITALITEC INTERNATIONAL Medizintechnik GmbH	1	2024–2024	Pure Global AI

Outside the US the count is of all the company's device registrations in that market, dental or not · matched by company name and country · registry data read 12 Nov 2026

Devices listed with FDA

What VITALITEC INTERNATIONAL Medizintechnik GmbH currently lists, by FDA device type, with the brand and model names on the listing.

Device type	Category	Role	Brands and models	Listed since
Surgical Rongeur ForcepsEMH · Class 1	Dental hand instruments	Lister	Rongeur Surgical Forceps	1992

Source: FDA establishment registration & device listing, 510(k) and product classification files · FDA data as of 2 Nov 2026 · snapshot 12 Nov 2026

Registered establishments

Establishment	Location	What it does
Vitalitec International Medizintechnik GmbHFDA reg. 8044057	BALGHEIM Baden-Wurttemberg, Germany	Repacker / relabeler

Sources

FDA establishment registration & device listing (search FDA, owner/operator 9005335). FDA 510(k) premarket notification file. FDA data as of 2 Nov 2026; snapshot 12 Nov 2026. The location shown is the address on FDA's record.