FDA device listing

Collection Cup, Urine Specimen Cup, Urine Plastic Container, Cuvette Cup, Sample Storage Specimen Vial Cup

FDA device listing 1289754791 · HANGZHOU WEIZE IMP & EXP CO., LTD

Key facts

Proprietary names Collection Cup, Urine Specimen Cup, Urine Plastic Container, Cuvette Cup, Sample Storage Specimen Vial Cup
Owner/operator HANGZHOU WEIZE IMP & EXP CO., LTD
Owner/operator number 10059980
Product codes FMH
Device names FMH - Container, Specimen, Sterile
Device class Class I
Classification regulations (21 CFR) 864.3250
Review panels Pathology
Registered establishments HANGZHOU WEIZE IMP & EXP CO., LTD
Establishment registrations 3015277818
FEI numbers 3015277818
Establishment operations Foreign Exporter, 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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