FDA device listing

pituitary rongeur

FDA device listing 1206046606 · Changzhou Geasure Medical Apparatus and Instruments Co., Ltd

Key facts

Proprietary names pituitary rongeur
Owner/operator Changzhou Geasure Medical Apparatus and Instruments Co., Ltd
Owner/operator number 10086983
Product codes HTX
Device names HTX - Rongeur
Device class Class I
Classification regulations (21 CFR) 888.4540
Review panels Orthopedic
Registered establishments CHANGZHOU GEASURE MEDICAL APPARATUS AND INSTRUMENTS CO., LTD
Establishment registrations 3026311512
FEI numbers 3026311512
Establishment operations Contract Manufacturer, 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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