UDI device identifier

SURESIGN™ Pregnancy Rapid Test 01000-0

UDI device identifier 00045611010000 · Guangzhou Decheng Biotechnology Co., LTD

Key facts

Primary DI 00045611010000
Brand name SURESIGN™ Pregnancy Rapid Test
Version or model 01000-0
Company Guangzhou Decheng Biotechnology Co., LTD
DUNS number 554534314
Product code LCX
GMDN term Total human chorionic gonadotropin IVD, kit, rapid ICT, clinical
Device class Class II
Single use Yes
Packaged sterile No
Implantable No
Publish date Jan 28, 2026
Version date Feb 5, 2026
Description 5ct 25mIU - Single Step Pregnancy Test

At a glance

  • None MAUDE reports citing this UDI
  • No Linked premarket submission
  • No EUDAMED counterpart found
  • 100–999 GUDID devices with this product code

Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.

About UDI device identifiers (GUDID)

The Global Unique Device Identification Database (GUDID) holds the device identifiers (UDI-DIs) and key attributes that labelers submit to the FDA for devices that carry a unique device identifier.

Source: U.S. FDA Global Unique Device Identification Database (GUDID), via NLM AccessGUDID · Source date:

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