FDA device listing

MiniLoad® Syringes

FDA device listing 1648383240 · Shanghai Mekon Medical Devices Co., Ltd.

Key facts

Proprietary names MiniLoad® Syringes
Owner/operator Shanghai Mekon Medical Devices Co., Ltd.
Owner/operator number 10059181
Premarket submissions K212544
Product codes FMF
Device names FMF - Syringe, Piston
Device class Class II
Classification regulations (21 CFR) 880.5860
Review panels General Hospital
Registered establishments SHANGHAI MEKON MEDICAL DEVICES CO., LTD.
Establishment registrations 3012552122
FEI numbers 3012552122
Establishment operations Foreign Exporter
Registration valid through 2026

At a glance

  • 1–9 Registered establishments listing this device
  • 1–9 UDI devices (GUDID) under the same submission
  • 1–9 Device listings citing the same submission
  • Yes 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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