Siemens Healthcare Diagnostics Inc. devices, product family

by Siemens Healthcare Diagnostics Inc. 9 variants Basic UDI-DI 0405686901962WD

Shared by every variant

Manufacturer: Siemens Healthcare Diagnostics Inc.(9)
Basic UDI-DI: 0405686901962WD
Risk class: Class B
Legislation: IVDR
EMDN category: URINE MULTI-CONSTITUENT TEST STRIPS (AUTOMATED)URINE MULTI-CONSTITUENT TEST STRIPS (MANUAL)
Market status: 9 on the market
Official record: EUDAMED public site — Open the EUDAMED public site, choose Devices, and search for the Basic UDI-DI 0405686901962WD.

1 certificate naming this Basic UDI-DI · EUDAMED

IX 1290554-7 Technical documentation · refdata.applicable-legislation.ivdr issued
Notified body 0197 · holder Siemens Healthcare Diagnostics Inc. · issued 12 May 2025 · expires 5 Jun 2028

0 recalls · FDA

No recall matched the devices on this page.

Recalls matched to the 9 devices listed on this page; other pages of the family can carry others.

9 devices · page 1 of 1

Variants of Siemens Healthcare Diagnostics Inc. devices, Basic UDI-DI 0405686901962WD
		UDI-DI	Size and differences
CLINITEK Microalbumin 2	10317957 / IVDR_69_TTN_DUB-C_B_NPT_REAG_De-Centralized Urin Stat	00630414975467	—	On the market
CLINITEK Microalbumin 2	10318739 / IVDR_69_TTN_DUB-C_B_NPT_REAG_De-Centralized Urin Stat	00630414602479	—	On the market
CLINITEK Microalbumin 2	10318844 / IVDR_69_TTN_DUB-C_B_NPT_REAG_De-Centralized Urin Stat	00842768026706	—	On the market
CLINITEK Microalbumin 2+	11306461 / IVDR_69_TTN_DUB-C_B_NPT_REAG_De-Centralized Urin Stat	00630414237855	—	On the market
CLINITEK Microalbumin 9	10285741 / IVDR_69_TTN_DUB-C_B_NPT_REAG_De-Centralized Urin Stat	00630414554907	—	On the market
Hema-Combistix	10324743 / IVDR_69_TTN_DUB-C_B_NPT_REAG_De-Centralized Urin Stat	00630414985046	—	On the market
Microalbustix	10321658 / IVDR_69_TTN_DUB-C_B_NPT_REAG_De-Centralized Urin Stat	00630414985008	—	On the market
URISTIX	10320006 / IVDR_69_TTN_DUB-C_B_NPT_REAG_De-Centralized Urin Stat	00630414597133	—	On the market
URISTIX	10322126 / IVDR_69_TTN_DUB-C_B_NPT_REAG_De-Centralized Urin Stat	00630414985015	—	On the market