FDA device listing

Sensi-Care Adhesive Releaser

FDA device listing 1555231383 · Aurena Laboratories AB

Key facts

Proprietary names Sensi-Care Adhesive Releaser
Owner/operator Aurena Laboratories AB
Owner/operator number 10044962
Product codes KOX
Device names KOX - Solvent, Adhesive Tape
Device class Class I
Classification regulations (21 CFR) 878.4730
Review panels General & Plastic Surgery
Registered establishments AURENA LABORATORIES AB
Establishment registrations 3006542993
FEI numbers 3004080052
Establishment operations Contract Manufacturer, 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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