FDA device listing

MicroGard II,MicroGard II Filter Kit

FDA device listing 1230928622 · Riensch & Held GmbH & Co. KG

Key facts

Proprietary names MicroGard II,MicroGard II Filter Kit
Owner/operator Riensch & Held GmbH & Co. KG
Owner/operator number 10050512
Product codes CAH
Device names CAH - Filter, Bacterial, Breathing-Circuit
Device class Class II
Classification regulations (21 CFR) 868.5260
Review panels Anesthesiology
Registered establishments RIENSCH & HELD GMBH & CO. KG
Establishment registrations 3003332988
FEI numbers 3003332988
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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