FDA device listing

Instrument, Manual, Surgical, General Use

FDA device listing 1361806022 · I-Medical Asia Company Limited

Key facts

Proprietary names Instrument, Manual, Surgical, General Use
Owner/operator I-Medical Asia Company Limited
Owner/operator number 10085603
Product codes MDM
Device names MDM - Instrument, Manual, Surgical, General Use
Device class Class I
Classification regulations (21 CFR) 878.4800
Review panels General & Plastic Surgery
Registered establishments I-MEDICAL ASIA COMPANY LIMITED
Establishment registrations 3015806723
FEI numbers 3015806723
Establishment operations Foreign Exporter
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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