EU → US Device Access

Philips Medizin Systeme Böblingen GmbH

DE-MF-000006026 · Germany · Böblingen

Philips Medizin Systeme Böblingen GmbH is registered in the European database on medical devices as a manufacturer, with 394 devices declared. It was not found in the U.S. FDA device establishment register.

What this manufacturer declares

Class IIa277
Class IIb117

Most frequent device types declared: Lead sets w/wo SpO2 adapter and Cables, Easy Care and Gentle Care NIBP Cuffs, Lead Set/Patient Cable/Lead Upgrade Kit, Neonatal Single & Soft-Single NIBP Cuffs, Single Patient Use Disposable \.

Among these devices, 1 are declared sterile, 166 active, 127 with a measuring function.

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 EUDAMED394
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.

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