FDA device listing

Retractor, Vaginal

FDA device listing 1342907902 · MAX HAUSER SUDDEUTSCHE CHIRURGIEMECHANIK GMBH

Key facts

Owner/operator MAX HAUSER SUDDEUTSCHE CHIRURGIEMECHANIK GMBH
Owner/operator number 8010422
Product codes HDL
Device names HDL - Retractor, Vaginal
Device class Class I
Classification regulations (21 CFR) 884.4520
Review panels Obstetrics/Gynecology
Registered establishments MAX HAUSER SUDDEUTSCHE CHIRURGIEMECHANIK GMBH
Establishment registrations 8010422
FEI numbers 3008238512
Establishment operations Manufacturer
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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