FDA device listing

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FDA device listing 1301488151 · SIGNUS Medizintechnik GmbH

Key facts

Proprietary names template
Owner/operator SIGNUS Medizintechnik GmbH
Owner/operator number 9034279
Product codes HWT
Device names HWT - Template
Device class Class I
Classification regulations (21 CFR) 888.4800
Review panels Orthopedic
Registered establishments SIGNUS MEDIZINTECHNIK GMBH
Establishment registrations 9615021
FEI numbers 1000615957
Establishment operations Complaint File Establishment, Foreign Exporter, Specification Developer
Registration valid through 2026

At a glance

  • 1–9 Registered establishments listing this device
  • None listed Premarket submission listed

Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.

About FDA device listings

Establishments that make or process devices for the U.S. market must list each device with the FDA. A listing records the device's proprietary names, product codes and premarket submission, and every registered establishment that handles it.

Source: U.S. Food and Drug Administration (FDA), Establishment Registration and Device Listing database

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