EU → US Device Access

SLH Microtech GmbH

DE-MF-000020864 · Germany · HEPPENHEIM (BERGSTR.)

SLH Microtech GmbH is registered in the European database on medical devices as a manufacturer, with 235 devices declared. It was not found in the U.S. FDA device establishment register.

What this manufacturer declares

Class IIb216
Class IIa19

Most frequent device types declared: DC Superstructures, DCX Implant, Ø: 3.5mm L: 10 mm, DC Ø: 3.5mm L: 8 mm, Ø: 4.1mm L: 6.5 mm.

Among these devices, 31 are declared sterile, 216 implantable.

No authorised representative is recorded for these devices. For a manufacturer established outside the Union that would be unusual; for one established inside it, it is normal.

United States market access

FDA establishment registerNot found in the FDA register
Devices in EUDAMED235
Country of registrationGermany
⚠️ Absence here is not proof of absence from the market. A manufacturer may reach the United States through a distributor registered under its own name, or under a corporate name we could not match. We publish what we measured, not what we inferred.

Notified body certificates

CertificateStatusExpiry
2975-MED-2616701issued2031-06-15

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