FDA device listing

Aydmed Urinalysis Reagent Test Strips - 9 Parameters Urinalysis Reagent Test Strips - 9 Parameters,Aydmed Urinalysis…

FDA device listing 2059272906 · Hague Global Limited

Key facts

Proprietary names Aydmed Urinalysis Reagent Test Strips - 9 Parameters Urinalysis Reagent Test Strips - 9 Parameters,Aydmed Urinalysis Reagent Test Strips 9 Parameters, Urinalysis Reagent Test Strips 9 Parameters,Aydmed Urinalysis Reagent Test Strips, Urinalysis Reagent Test Strips
Owner/operator Hague Global Limited
Owner/operator number 10087001
Product codes CEN
Device names CEN - Dye-Indicator, Ph (Urinary, Non-Quantitative)
Device class Class I
Classification regulations (21 CFR) 862.1550
Review panels Clinical Chemistry
Registered establishments HAGUE GLOBAL LIMITED
Establishment registrations 3016712364
FEI numbers 3016712364
Establishment operations Repackager/Relabeler
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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