FDA device listing

VOLGOCARE

FDA device listing 1998536911 · VOLGO CARE INTERNATIONAL (PRIVATE) LIMITED

Key facts

Proprietary names VOLGOCARE
Owner/operator VOLGO CARE INTERNATIONAL (PRIVATE) LIMITED
Owner/operator number 10090904
Product codes HGN
Device names HGN - Stethoscope, Fetal
Device class Class I
Classification regulations (21 CFR) 884.2900
Review panels Obstetrics/Gynecology
Registered establishments VOLGO CARE INTERNATIONAL (PRIVATE) LIMITED
Establishment registrations 3031564283
FEI numbers 3031564283
Establishment operations Contract Manufacturer, Manufacturer, Remanufacturer, 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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