FDA device listing

Electrosurgical, Cutting & Coagulation & Accessories

FDA device listing 1369737237 · Tecno Instruments (Pvt) Ltd.

Key facts

Owner/operator Tecno Instruments (Pvt) Ltd.
Owner/operator number 9019852
Premarket submissions K170107
Product codes GEI
Device names GEI - Electrosurgical, Cutting & Coagulation & Accessories
Device class Class II
Classification regulations (21 CFR) 878.4400
Review panels General & Plastic Surgery
Registered establishments TECNO INSTRUMENTS (PVT.) LTD.
Establishment registrations 9613563
FEI numbers 3002808325
Establishment operations Foreign Exporter, Manufacturer
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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