UDI device identifier

Equaline Digital Wide-Tip Pregnancy Test

UDI device identifier 00041163504448 · SPD SWISS PRECISION DIAGNOSTICS GMBH

Key facts

Primary DI 00041163504448
Brand name Equaline
Version or model Digital Wide-Tip Pregnancy Test
Company SPD SWISS PRECISION DIAGNOSTICS GMBH
DUNS number 483609579
Product code LCX
GMDN term Total human chorionic gonadotropin IVD, kit, rapid ICT, clinical
Premarket submission K060128
Device class Class II
Single use Yes
Packaged sterile No
Implantable No
Publish date Mar 31, 2025
Version date Apr 8, 2025
Description SuperValu DPS DIG Wide-Tip Blue

At a glance

  • None MAUDE reports citing this UDI
  • Yes 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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