FDA device listing

Instrument, Surgical, Non-Powered

FDA device listing 1123221303 · addn solutions GmbH & Co. KG

Key facts

Owner/operator addn solutions GmbH & Co. KG
Owner/operator number 10091519
Product codes HAO
Device names HAO - Instrument, Surgical, Non-Powered
Device class Class I
Classification regulations (21 CFR) 882.4535
Review panels Neurology
Registered establishments ADDN SOLUTIONS GMBH & CO. KG
Establishment registrations 3033536312
FEI numbers 3033536312
Establishment operations Contract 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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