FDA device listing

drive medical

FDA device listing 1780382654 · H&K International Trade Limited (China)

Key facts

Proprietary names drive medical
Owner/operator H&K International Trade Limited (China)
Owner/operator number 10032555
Product codes OHY
Device names OHY - Pill Crusher/Cutter
Device class Class I
Classification regulations (21 CFR) 880.6430
Review panels General Hospital
Registered establishments H&K INTERNATIONAL TRADE LIMITED (CHINA), Jinhua Twinstar Tools Co. Ltd
Establishment registrations 3008386507, 3008388419
FEI numbers 3008386507, 3008388419
Establishment operations Foreign Exporter, 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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