FDA device listing

Zhejiang Haisheng compatible DBPT series disposable blood pressure transducer

FDA device listing 1532800432 · Orantech Inc.

Key facts

Proprietary names Zhejiang Haisheng compatible DBPT series disposable blood pressure transducer
Owner/operator Orantech Inc.
Owner/operator number 10058634
Premarket submissions K152472
Product codes DRS
Device names DRS - Transducer, Blood-Pressure, Extravascular
Device class Class II
Classification regulations (21 CFR) 870.2850
Review panels Cardiovascular
Registered establishments ORANTECH INC.
Establishment registrations 3013783488
FEI numbers 3013783488
Establishment operations Foreign Exporter
Registration valid through 2026

At a glance

  • 1–9 Registered establishments listing this device
  • 10–99 UDI devices (GUDID) under the same submission
  • 1–9 Device listings citing the same submission
  • Yes 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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