FDA device listing

Digital Basal Thermometer, Model: DT002, DT003, DT004, DT005, DT006;,Digital Thermometer, Model: DT001, DT007…

FDA device listing 1990821963 · Guangzhou Berrcom Medical Device Co., Ltd

Key facts

Proprietary names Digital Basal Thermometer, Model: DT002, DT003, DT004, DT005, DT006;,Digital Thermometer, Model: DT001, DT007, DT008;,Digital Thermometer, Model: DT007, DT008, DT113, DT116, DT117, DT119;,Digital Thermometer, Model: DT101, DT102,Ear Thermometer, Model: ET001, MD-H30, ET003, ET005, ET008, ET009;,Ear Thermometer, Model: ET101, ET102, ET103, ET106, ET107, ET108;,Non-contact Infrared Thermometer…
Owner/operator Guangzhou Berrcom Medical Device Co., Ltd
Owner/operator number 10032524
Product codes SDV
Device names SDV - Clinical Electronic Thermometer
Device class Class II
Classification regulations (21 CFR) 880.2910
Review panels General Hospital
Registered establishments Guangzhou Berrcom Medical Device Co., Ltd
Establishment registrations 3008395508
FEI numbers 3008395508
Establishment operations Foreign Exporter, Manufacturer, Specification Developer
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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