FDA device listing

Doyan Viginal Speculum,SPECULUM, VAGINAL, METAL

FDA device listing 2049919489 · ULTRA SURGICAL (PVT.) LTD

Key facts

Proprietary names Doyan Viginal Speculum,SPECULUM, VAGINAL, METAL
Owner/operator ULTRA SURGICAL (PVT.) LTD
Owner/operator number 9024763
Product codes HDF
Device names HDF - Speculum, Vaginal, Metal
Device class Class I
Classification regulations (21 CFR) 884.4520
Review panels Obstetrics/Gynecology
Registered establishments ULTRA SURGICAL (PVT.) LTD
Establishment registrations 9681540
FEI numbers 3000321209
Establishment operations Manufacturer
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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