FDA device listing

711902,AS-FLOS,AS-FLOS F5029,F5020D F5028 F5023 F5020 F5108 F5530B1 F5530 F5010 RST5010 AS-KIDS-FLOS RST5002plus…

FDA device listing 1243536269 · RISUN TECHNOLOGY (VIETNAM) COMPANY LIMITED

Key facts

Proprietary names 711902,AS-FLOS,AS-FLOS F5029,F5020D F5028 F5023 F5020 F5108 F5530B1 F5530 F5010 RST5010 AS-KIDS-FLOS RST5002plus AS-FLOS-PRO-BK AS-FLOS-PRO-WH,F5025A, 711902, F5336,HOC700 HOC760 HOC600 HOC660 F5025
Owner/operator RISUN TECHNOLOGY (VIETNAM) COMPANY LIMITED
Owner/operator number 10088396
Product codes EFS
Device names EFS - Unit, Oral Irrigation
Device class Class I
Classification regulations (21 CFR) 872.6510
Review panels Dental
Registered establishments RISUN TECHNOLOGY (VIET NAM) COMPANY LIMITED
Establishment registrations 3027645138
FEI numbers 3027645138
Establishment operations Contract Manufacturer, Foreign Exporter, 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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