FDA device listing

RiEye Mk2S Operating table R5,RiEye Mk2S Operating table R6,RiEye Mk2S Operating table R7

FDA device listing 1029344790 · Rini Ergoteknik AB

Key facts

Proprietary names RiEye Mk2S Operating table R5,RiEye Mk2S Operating table R6,RiEye Mk2S Operating table R7
Owner/operator Rini Ergoteknik AB
Owner/operator number 9046622
Product codes GDC
Device names GDC - Table, Operating-Room, Electrical
Device class Class I
Classification regulations (21 CFR) 878.4960
Review panels General & Plastic Surgery
Registered establishments RINI ERGOTEKNIK AB
Establishment registrations 9710385
FEI numbers 3003138129
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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