FDA device listing

Working Insert

FDA device listing 1272555084 · jr-medizintechnik GmbH & Co KG

Key facts

Proprietary names Working Insert
Owner/operator jr-medizintechnik GmbH & Co KG
Owner/operator number 10087609
Product codes HIH
Device names HIH - Hysteroscope (And Accessories)
Device class Class II
Classification regulations (21 CFR) 884.1690
Review panels Obstetrics/Gynecology
Registered establishments JR-MEDIZINTECHNIK GMBH & CO KG
Establishment registrations 3025482817
FEI numbers 3025482817
Establishment operations Contract 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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