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MACHEREY-NAGEL GmbH & Co. KG devices, product family

by MACHEREY-NAGEL GmbH & Co. KG 57 variants Basic UDI-DI 4046681151040VR

Shared by every variant

Manufacturer
MACHEREY-NAGEL GmbH & Co. KG(57)
Basic UDI-DI
4046681151040VR
Risk class
Class B
Legislation
IVDR
EMDN category
URINE SINGLE TEST STRIPS (INCL. TABLETS)
Market status
47 on the market10 not intended for the eu market
Official record
EUDAMED public site — Open the EUDAMED public site, choose Devices, and search for the Basic UDI-DI 4046681151040VR.

Certificates

1 certificate naming this Basic UDI-DI · EUDAMED

  • IX 1038121-2 Technical documentation · refdata.applicable-legislation.ivdr issued
    Notified body 0197 · holder MACHEREY-NAGEL GmbH & Co. KG · issued 22 Nov 2024 · expires 15 May 2028

Recalls

1 recall · 1 ongoing · FDA

  • Z-1834-2024 Class II · ongoing · 4 Apr 2024
    The reason for the recall is one of the test pads, for the parameter leukocytes, was missing on some of the test strips. The issue was identified by a consumer by way of a Henry Schein Inc. (HSI) customer complaint. This problem can potentially result in the possibility that the parameter leucocytes (a non-specific marker for urinary track infections and an indicator for inflammatory renal processes) is interpreted instrumentally as a false negative. The following HSI item number and lot number were affected: Urispec 11-Way, #102-2285, LOT 65402.

Recalls matched to the 50 devices listed on this page; other pages of the family can carry others.

Variants

57 devices · page 1 of 2

Variants of MACHEREY-NAGEL GmbH & Co. KG devices, Basic UDI-DI 4046681151040VR
UDI-DISize and differences
hoyer-6 MD5073 / Medi-Test URYXXON® Stick 1004046681141768 —On the market
Medi Test Combi 9® 93023 / Medi-Test URYXXON® Stick 1004046681000294 —On the market
Medi Test Combi 9® 930879 / Medi-Test URYXXON® Stick 1004046681149252 —On the market
Medi-Test Combi 10® L 93058 / Medi-Test URYXXON® Stick 1004046681000324 —On the market
Medi-Test Combi 10® L 93079 / Medi-Test URYXXON® Stick 1004046681000317 —On the market
Medi-Test Combi 10® SGL 93067.004 / Medi-Test URYXXON® Stick 1004046681165269 —On the market
Medi-Test Combi 10® SGL 93067.2 / Medi-Test URYXXON® Stick 1004046681001116 —Not intended for the EU market
Medi-Test Combi 11 93060 / Medi-Test URYXXON® Stick 1004046681000331 —On the market
Medi-Test Combi 11 930871 / Medi-Test URYXXON® Stick 1004046681000805 —On the market
Medi-Test Combi 2 93015.004 / Medi-Test URYXXON® Stick 1004046681171727 —On the market
Medi-Test Combi 2 93015 / Medi-Test URYXXON® Stick 1004046681000126 —On the market
Medi-Test Combi 2 93037.204483 / Medi-Test URYXXON® Stick 1004046681164668 —Not intended for the EU market
Medi-Test Combi 2 93037 / Medi-Test URYXXON® Stick 1004046681000133 —On the market
Medi-Test Combi 3 93050.205567 / Medi-Test URYXXON® Stick 1004046681142499 —Not intended for the EU market
Medi-Test Combi 3A® 93007 / Medi-Test URYXXON® Stick 1004046681000140 —On the market
Medi-Test Combi 3A® 93030 / Medi-Test URYXXON® Stick 1004046681000157 —On the market
Medi-Test Combi 5 93009 / Medi-Test URYXXON® Stick 1004046681000164 —On the market
Medi-Test Combi 5L 93008.143993 / Medi-Test URYXXON® Stick 1004046681167126 —On the market
Medi-Test Combi 5N® 93035 / Medi-Test URYXXON® Stick 1004046681000188 —On the market
Medi-Test Combi 5N® 93036 / Medi-Test URYXXON® Stick 1004046681000195 —On the market
Medi-Test Combi 5N® MED 125 / Medi-Test URYXXON® Stick 1004046681169984 —Not intended for the EU market
Medi-Test Combi 5S 93055 / Medi-Test URYXXON® Stick 1004046681000201 —On the market
Medi-Test Combi 5S MED 135 / Medi-Test URYXXON® Stick 1004046681142482 —Not intended for the EU market
Medi-Test Combi 6A 93034 / Medi-Test URYXXON® Stick 1004046681000249 —On the market
Medi-Test Combi 7 93022 / Medi-Test URYXXON® Stick 1004046681000263 —On the market
Medi-Test Combi 7L 93031.143993 / Medi-Test URYXXON® Stick 1004046681167133 —On the market
Medi-Test Combi 8L 93021 / Medi-Test URYXXON® Stick 1004046681000270 —On the market
Medi-Test Glucose 93024 / Medi-Test URYXXON® Stick 1004046681000010 —On the market
Medi-Test Glucose / Keton 93020 / Medi-Test URYXXON® Stick 1004046681001208 —On the market
Medi-Test Glucose / Keton 93025 / Medi-Test URYXXON® Stick 1004046681001215 —On the market
Medi-Test Keton 93005 / Medi-Test URYXXON® Stick 1004046681000065 —On the market
Medi-Test Keton 93028 / Medi-Test URYXXON® Stick 1004046681000072 —On the market
Medi-Test Nitrit 93006 / Medi-Test URYXXON® Stick 1004046681000089 —On the market
Medi-Test Nitrit 93029 / Medi-Test URYXXON® Stick 1004046681000096 —On the market
Medi-Test Protein 2 93004 / Medi-Test URYXXON® Stick 1004046681000041 —On the market
Medi-Test Protein 2 93027 / Medi-Test URYXXON® Stick 1004046681000058 —On the market
Medi-Test Protein 2 MED 120 / Medi-Test URYXXON® Stick 1004046681142772 —Not intended for the EU market
Medi-Test URYXXON® Stick 10 93068.004 / Medi-Test URYXXON® Stick 1004046681165283 —On the market
Medi-Test URYXXON® Stick 10 93068.005 / Medi-Test URYXXON® Stick 1004046681165245 —On the market
Medi-Test URYXXON® Stick 10 93068 / Medi-Test URYXXON® Stick 1004046681000379 —On the market
Medi-Test URYXXON® Stick 10 930872 / Medi-Test URYXXON® Stick 1004046681001000 —On the market
Uri Stix 10 M2109641 / Medi-Test URYXXON® Stick 1004046681170003 —On the market
Uri Stix 10GLS M2109642 / Medi-Test URYXXON® Stick 1004046681170010 —On the market
Uri Stix 6 M2109643 / Medi-Test URYXXON® Stick 1004046681169991 —On the market
URINE TEST STRIP 9+ LEUKO 97-99660 / Medi-Test URYXXON® Stick 1004046681164910 —On the market
Urispec PLUS 10 SL PLUS 900-2634 / Medi-Test URYXXON® Stick 1004046681170300 —On the market
Urispec PLUS 11 SYS PLUS 900-2635 / Medi-Test URYXXON® Stick 1004046681164897 —On the market
Urispec PLUS 3 PLUS 900-2637 / Medi-Test URYXXON® Stick 1004046681164859 —On the market
Urispec PLUS 5+ LEUKO PLUS 900-2638 / Medi-Test URYXXON® Stick 1004046681164866 —On the market
Urispec PLUS 9+ LEUKO PLUS 900-2633 / Medi-Test URYXXON® Stick 1004046681164873 —On the market