EPflex Feinwerktechnik
Dettingen an der Erms, Germany
German OEM manufacturer of guidewires, nitinol stone retrieval baskets, snares and stylets for minimally invasive medicine, founded in 1994.
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Medical Instrument Companies in Dettingen an der Erms, Germany
Business types in Dettingen an der Erms
Verified specialties in Dettingen an der Erms
Regulation in Germany
Germany is in the EU / EEA, so the EU framework applies.
Regulator: European Commission (DG SANTE) with national competent authorities of EU/EEA Member States
Two EU regulations govern medical devices and IVDs in the EU/EEA; devices need CE marking after the conformity assessment route set by their risk class.
From the sourced EU MDR / IVDR entry, checked 29 October 2026. General information, not legal advice. Requirements for Germany · All medical certifications
Frequently asked questions
How do I search the whole Tuttlingen area, not just Tuttlingen itself?
The directory files companies under the town in their address, so companies in the Tuttlingen area are spread over many city pages. Besides Tuttlingen (more than 50 companies), there are separate pages for Tuttlingen-Nendingen, Wurmlingen (about 10), Emmingen-Liptingen, Neuhausen ob Eck, Rietheim-Weilheim, Seitingen-Oberflacht, Spaichingen, Frittlingen, Mühlheim an der Donau and Fridingen, plus several smaller towns.
Note that "Emmingen" and "Emmingen-Liptingen" are separate pages, as are "Tuttlingen" and "Tuttlingen-Nendingen", so check both. For a single list of all German companies, use the Germany country page.
What must a German importer check when bringing instruments in from outside the EU?
Under Article 13 of the EU MDR, an importer established in the EU, for example a German company buying from a Pakistani or Chinese factory, must verify before placing the device on the market that:
- the device is CE marked and has an EU Declaration of Conformity;
- the manufacturer is identified and has designated an EU authorized representative;
- labeling and instructions for use meet the MDR, and a UDI has been assigned where required.
The importer must add its own name and address to the device, packaging or an accompanying document, register in EUDAMED and keep complaint and traceability records. An importer that changes the labeling or intended purpose may take on manufacturer obligations. Find German importers and distributors on the Germany country page.