UDI device identifier

Chemstrip 5 OB Test Strips 11893467160

UDI device identifier 00075537018934 · Roche Diagnostics GmbH

Key facts

Primary DI 00075537018934
Brand name Chemstrip 5 OB Test Strips
Version or model 11893467160
Catalog number 11893467160
Company Roche Diagnostics GmbH
DUNS number 315028860
Product code CDM
GMDN term Multiple urine analyte IVD, kit, rapid colorimetric, clinical
Premarket submission K032437
Device class Class I
Single use Yes
Packaged sterile No
Implantable No
Publish date Sep 20, 2016
Version date Nov 28, 2022

At a glance

  • None MAUDE reports citing this UDI
  • Yes Linked premarket submission
  • No EUDAMED counterpart found
  • 10–99 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:

Browse all UDI device identifiers (GUDID)