FDA device listing

HY-DROP,Hy-Drop Forte

FDA device listing 1732887299 · Polydentia S.A.

Key facts

Proprietary names HY-DROP,Hy-Drop Forte
Owner/operator Polydentia S.A.
Owner/operator number 9076845
Product codes KYX
Device names KYX - Dispenser, Liquid Medication
Device class Class I
Classification regulations (21 CFR) 880.6430
Review panels General Hospital
Registered establishments POLYDENTIA S.A.
Establishment registrations 8031054
FEI numbers 1000558210
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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