FDA device listing

Fora Comfort 2 in 1 TD-3250C Blood Glucose and Blood Pressure Monitoring System

FDA device listing 1091845799 · TAIDOC TECHNOLOGY CORPORATION

Key facts

Proprietary names Fora Comfort 2 in 1 TD-3250C Blood Glucose and Blood Pressure Monitoring System
Owner/operator TAIDOC TECHNOLOGY CORPORATION
Owner/operator number 9058384
Premarket submissions K080014
Product codes CGA, DXN, NBW
Device names CGA - Glucose Oxidase, Glucose, DXN - System, Measurement, Blood-Pressure, Non-Invasive, NBW - System, Test, Blood Glucose, Over The Counter
Device class Class II
Classification regulations (21 CFR) 862.1345, 870.1130
Review panels Cardiovascular, Clinical Chemistry
Registered establishments TAIDOC TECHNOLOGY CORPORATION
Establishment registrations 3004145393
FEI numbers 3004145393
Establishment operations 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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