FDA device listing

SealSafe

FDA device listing 1115716608 · THE ANDWIN CORP.

Key facts

Proprietary names SealSafe
Owner/operator THE ANDWIN CORP.
Owner/operator number 2027344
Product codes IQG
Device names IQG - Adaptor, Holder, Syringe
Device class Class I
Classification regulations (21 CFR) 890.5050
Review panels Physical Medicine
Registered establishments ANDWIN SCIENTIFIC
Establishment registrations 2027344
FEI numbers 2027344
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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