FDA device listing

Media Reproductive Exempt

FDA device listing 1535757292 · FERTIPRO N.V.

Key facts

Proprietary names Media Reproductive Exempt
Owner/operator FERTIPRO N.V.
Owner/operator number 9046065
Product codes QKI
Device names QKI - Media, Reproductive, Exempt
Device class Class II
Classification regulations (21 CFR) 884.6180
Review panels Obstetrics/Gynecology
Registered establishments FERTIPRO N.V.
Establishment registrations 3003272500
FEI numbers 3003272500
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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