Manufacturer

Siemens Healthcare Diagnostics Products

Germany, United Kingdom (ex Northern Ireland)Legal entities : Siemens Healthcare Diagnostics Products GmbH, Siemens Healthcare Diagnostics Products Ltd.

First countries of placing on the market declared in EUDAMED : Belgium, Germany

Public contracts won : Belgium 1

EU representative : Siemens Healthcare Diagnostics Manufacturing Limited (Ireland)

Website contact@siemens-healthineers.com

76 categories, 153 models including 153 on the market, 2 countries

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On the market
No longer marketed
93/42 Former directive, not yet certified under the MDR
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Category	EMDN code	Registered models	Class	Contact
Control plasma for haemostasis	W0103020702	Control Plasma N IVDR_27_MAR EB_C_PROF_REAG_CPN3 refs Control Plasma P IVDR_27_MAR EB_C_PROF_REAG_CPP3 refs Dade Ci-Trol 1 IVDR_27_MAR EB_C_PROF_REAG_Ci-Trol 13 refs Dade Ci-Trol 2 IVDR_27_MAR EB_C_PROF_REAG_Ci-Trol 23 refs Dade Ci-Trol 3 IVDR_27_MAR EB_C_PROF_REAG_Ci-Trol 33 refs 4 others Dade Ci-Trol Heparin Control, High IVDR_27_MAR EB_C_REAG_Ci-Trol_Hep_Con3 refs Dade Data-Fi Abnormal Fibrinogen Control IVDR_27_MAR EB_C_REAG_Data-Fi_Abn_Fib_Con2 refs LA Control High IVDR_27_MAR EB_B_REAG_LA_Con3 refs ProC Control Plasma IVDR_27_MAR EB_C_REAG_ProC_Con2 refs	B, C IVDR	EUDAMED record Report an error
Automated immunochemistry analysers - consumables	W0201020185	IMMULITE 2000 Allergen Tube Septa IVDR_27_LLB_DUB-C_A_INST_Allergen Tube Septa IMMULITE 2000 Nesting Cups 1mL for 12-mm and 13-mm sample tubes IVDR_27_LLB_DUB-C_A_INST_Nesting Cups2 refs IMMULITE 2000 Systems Diluent Tube Caps IVDR_27_LLB_DUB-C_A_INST_Diluent Tube Caps IMMULITE® 2000 Systems Allergen Tube Caps IVDR_27_LLB_DUB-C_A_INST_Allergen Tube Caps IMMULITE® 2000 Systems Microsampling Tube Caps IVDR_27_LLB_DUB-C_A_INST_MICROSAMPLING TUBE Caps 1 other IMMULITE® 2000 Systems Reaction Tubes IVDR_27_LLB_DUB-C_A_INST_Reaction Tubes	A IVDR	EUDAMED record Report an error
Calibration plasma for haemostasis	W0103020701	Dabigatran Standards IVDR_27_MAR EB_C_REAG_Dabi_Stand2 refs Fibrinogen Calibrator Kit IVDR_27_MAR EB_C_KIT_Fib_Cal2 refs INNOVANCE Apixaban Standards IVDR_27_MAR EB_C_INN_Riva_Stand3 refs INNOVANCE Heparin Calibrator IVDR_27_MAR EB_C_REAG_INN_Hep_Cal2 refs PT Multi-Calibrator IVDR_27_MAR EB_C_PROF_KIT_PT-Multi_Cal2 refs 1 other Standard Human Plasma IVDR_27_MAR EB_C_PROF_REAG_SHP3 refs	C IVDR	EUDAMED record Report an error
Coagulometers - consumables	W0202020185	BC Validation Kit IVDR_27_MAR EB_A_BC_Valid_Kit BCS System Cuvette Rotors IVDR_27_MAR EB_A_BCS_Cuv_Rotor Behring Coagulation Cup IVDR_27_MAR EB_A_Behring_Coag_Cup BFT II Analyzer IVDR_27_MAR EB_A_Cuv_BFT_II2 refs Dade PFA Priming Cartridges IVDR_27_MAR EB_A_PFA_Priming_Cartr 1 other Dade PFA Vacuum Cups IVDR_27_MAR EB_A_PFA_Vac_Cups	A IVDR	EUDAMED record Report an error
Haemostasis controls - other	W0103020799	Dabigatran Controls IVDR_27_MAR EB_C_REAG_Dabi_Con2 refs INNOVANCE Apixaban Controls IVDR_27_MAR EB_C_INN_Riva_Cons3 refs INNOVANCE D-Dimer 2.0 CONTROL 1 IVDR_27_MAR EB_C_PROF_INN_D_Di_Con_23 refs INNOVANCE D-Dimer Controls IVDR_27_MAR EB_C_PROF_REAG_INN_D-Di_Con3 refs INNOVANCE Heparin LMW Control 1 IVDR_27_MAR EB_C_REAG_INN_Hep_LMW_Con3 refs 1 other INNOVANCE Heparin UF Control 1 IVDR_27_MAR EB_C_REAG_INN_Hep_UF_Con3 refs	C IVDR	EUDAMED record Report an error
Fibrinogen assays (factor i)	W0103020201	Antiserum to Human Fibrinogen IVDR_27_MAR EB_C_REAG_AS_FIB Dade Fibrinogen Determination Reagents IVDR_27_MAR EB_C_KIT_Fib_Determ_Reag3 refs Dade Thrombin Reagent IVDR_27_MAR EB_C_REAG_Thromb_Reag3 refs Multifibren U IVDR_27_MAR EB_C_REAG_Multifib_U3 refs N Antiserum to Human Fibrinogen IVDR_27_MAR EB_C_REAG_N_AS_FIB	C IVDR	EUDAMED record Report an error
Haemostasis reagents - other	W01030299	Cleaner SCS IVDR_27_MAR EB_A_REAG_Clean_SCS Dade Hepzyme IVDR_27_MAR EB_A_PROF_REAG_Hepzyme2 refs Heterophilic Blocking Solution IVDR_27_MAR_EB_A_PROF_MICROB_ANIM_Hetero_Block_Sol Probe Cleaner H IVDR_27_MAR EB_A_Probe_REAG_Cleaner_H Washing Solution for Coagulation Analyzers IVDR_27_MAR EB_A_REAG_Wash_Sol_Coag_Analyzer	A IVDR	EUDAMED record Report an error
Activated partial thromboplastin time	W0103020102	Dade Actin Activated Cephaloplastin Reagent IVDR_27_MAR EB_C_PROF_REAG_Actin3 refs Dade Actin FS Activated PTT Reagent IVDR_27_MAR EB_C_PROF_REAG_Actin_FS3 refs Dade Actin FSL Activated PTT Reagent IVDR_27_MAR EB_C_PROF_REAG_Actin_FSL3 refs Pathromtin SL IVDR_27_MAR EB_C_PROF_REAG_Pathr_SL3 refs	C IVDR	EUDAMED record Report an error
Antithrombin	W0103020602	Antiserum to Human Antithrombin III IVDR_27_MAR EB_C_REAG _AS_ATIII Berichrom Antithrombin III (A) IVDR_27_MAR EB_C_PROF_KIT_Ber_ATIII3 refs INNOVANCE Antithrombin IVDR_27_MAR EB_C_PROF_KIT_INN_AT3 refs N Antiserum to Human Antithrombin III IVDR_27_MAR EB_C_REAG _N_AS_ATIII	C IVDR	EUDAMED record Report an error
Buffers (haemostasis)	W0103020903	Dade CA System Buffer IVDR_27_MAR EB_A_PROF_REAG_CA_Sys_Buff3 refs Dade Owren's Veronal Buffer IVDR_27_MAR EB_A_REAG_OVB3 refs Imidazole Buffer Solution IVDR_27_MAR EB_A_REAG_Imidazol INNOVANCE D-Dimer 2.0 DILUENT IVDR_27_MAR EB_a_PROF_INN_D_Di_Sam_Dil_22 refs	A IVDR	EUDAMED record Report an error
D-dimer	W0103020503	IMMULITE 2000 D-Dimer IVDR_67_LLB_DUB-C_C_KIT_D-Dimer INNOVANCE D-Dimer 2.0 IVDR_27_MAR EB_C_PROF_KIT_INN_D-Di_22 refs INNOVANCE D-Dimer IVDR_27_MAR EB_C_PROF_KIT_INN_D-Di3 refs INNOVANCE D-Dimer Sample Diluent IVDR_27_MAR EB_A_PROF_REAG_NN_D-Di_Sam_Dil3 refs	A, C IVDR	EUDAMED record Report an error
Limited panel immunochemistry analysers - software accessories	W0201020282	CSF Assessment Kit IVDD_27_MAR EB_A_CFS_Ass_Kit98/79 Kidney Assessment Kit IVDD_27_MAR EB_A_Kidn_Ass_Kit98/79 Multiple Sclerosis Assessment Kit IVDR_27_MAR EB_A_MS_Ass_Kit Nutritional Assessment Kit IVDD_27_MAR EB_A_Nutri_Ass_Kit98/79	A IVDR, 98/79	EUDAMED record Report an error
Thrombin time / reptilase / batroxobin time	W0103020103	Batroxobin Reagent IVDR_27_MAR EB_C_REAG_Batrox2 refs BC Thrombin Reagent IVDR_27_MAR EB_C_KIT_BC_Thromb IVDR_27_MAR EB_C_REAG_Thromboclotin2 refs Test Thrombin Reagent IVDR_27_MAR EB_C_KIT _Test_Thromb3 refs	C IVDR	EUDAMED record Report an error
Coagulation factor von willebrand (ag)	W0103020215	BC von Willebrand Reagent IVDR_27_MAR EB_C_REAG_BC_vW2 refs INNOVANCE VWF Ac IVDR_27_MAR EB_C_KIT_INN_VWF_Ac3 refs IVDR_27_MAR EB_B_KIT _vWF_Ag2 refs	B, C IVDR	EUDAMED record Report an error
Hepatitis b surface antigen	W0105020201	ADVIA Centaur Quantitative HBsAg (QHBs) IVDR_67_LLB_DUB-C_C_KIT_QHBs2 refs IMMULITE 2000 Anti-HBs DX LS_LEGACY_0063041496100298/79 IMMULITE 2000 HBsAg DX LS_LEGACY_0063041496158398/79	C IVDR, 98/79	EUDAMED record Report an error
Limited panel immunochemistry analysers - consumables	W0201020285	N Cuvette Segments for BN ProSpec IVDR_27_MAR EB_A_BN_PS_Cuv N Evaporation Caps for Control Vials (2.5 mL) IVDR_27_MAR EB_A_N_Eva_Caps2 refs N Predilution Wells IVDR_27_MAR EB_A_N_Predil_Well	A IVDR	EUDAMED record Report an error
Other virology controls - inf.imm.	W0105080804	IMMULITE CMV IgG Control IVDR_67_LLB_DUB-C_C_REAG_CMV IgG Controls IMMULITE Rubella IgG Controls IVDR_67_LLB_DUB-C_C_REAG_Rubella IgG Controls IMMULITE Rubella IgM Control Module IVDR_67_LLB_DUB-C_C_REAG_Rubella IgM Controls	C IVDR	EUDAMED record Report an error
Plasminogen	W0103020505	Antiserum to Human Plasminogen IVDR_27_MAR EB_B_REAG_AS_Plasm Berichrom Plasminogen IVDR_27_MAR EB_B_KIT_Ber_Plasm3 refs N Antiserum to Human Plasminogen IVDR_27_MAR EB_B_REAG_N_AS_Plasm	B IVDR	EUDAMED record Report an error
Pro c global	W0103020611	IVDR_27_MAR EB_C_KIT_ProC_Ac_R2 refs ProC Global IVDR_27_MAR EB_C_KIT_ProC_Glob2 refs Protein C Reagent IVDR_27_MAR EB_C_KIT _ProC_Reag2 refs	C IVDR	EUDAMED record Report an error
Various general purpose IVD instruments - IVD medical device software	W02079092	PRISCA 4.0 DX_LS_LEGACY_0063041422849598/79 PRISCA Connect DX_LS_LEGACY_0084276802704898/79 PRISCA Shared Database DX_LS_LEGACY_0084276802694298/79	– 98/79	EUDAMED record Report an error
Bacteriology controls - inf.imm.	W0105080801	IMMULITE H. pylori IgG Control Module IVDR_67_LLB_DUB-C_B_REAG_H. pylori IgG Control Module IMMULITE Syphilis Control Module IVDR_67_LLB_DUB-C_C_REAG_Syphilis Control Module	B, C IVDR	EUDAMED record Report an error
Coagulation factor viii	W0103020207	Coagulation Factor VIII Deficient Plasma IVDR_27_MAR EB_C_PROF_REAG_FVIII_Def_Pl2 refs Factor VIII Chromogenic Assay IVDR_27_MAR EB_C_KIT_FVIII_Chrom2 refs	C IVDR	EUDAMED record Report an error
Cytokines calibrators/controls	W01030608	IMMULITE Cytokine Control Module IVDR_67_LLB_DUB-C_B_REAG_Cytokine Control Module IMMULITE IL-10 Control Module IVDR_67_LLB_DUB-C_B_REAG_IL-10 Controls	B IVDR	EUDAMED record Report an error
Hepatitis virus controls - inf.imm.	W0105080802	ADVIA Centaur HBc Total 2 (HBcT2) Quality Control IVDR_67_LLB_DUB-C_D_REAG_HBc Total 2 QC2 refs ADVIA Centaur Quantitative HBsAg (QHBs) Quality Control IVDR_67_LLB_DUB-C_C_REAG_QHBs QC2 refs	C, D IVDR	EUDAMED record Report an error
Nephelometers	W0201020204	Atellica NEPH 630 System IVDR_27_MAR EB_A_INST_ANEPH630 BN II Evaporation Stoppers IVDR_27_MAR EB_A_INST_BNII3 refs	A IVDR	EUDAMED record Report an error
Protein s activity	W0103020608	INNOVANCE Free PS Ag IVDR_27_MAR EB_B_REAG_INN_Free_PS_Ag2 refs Protein S Ac IVDR_27_MAR EB_C_KIT_Prot_S_Ac3 refs	B, C IVDR	EUDAMED record Report an error
Prothrombin time ( quick test )	W0103020101	Dade Innovin IVDR_27_MAR EB_C_PROF_REAG_Innovin3 refs Thromborel S IVDR_27_MAR EB_C_PROF_REAG_Thr_S3 refs	C IVDR	EUDAMED record Report an error
Semi-automated coagulometers	W0202020101	BFT II Analyzer IVDR_27_MAR EB_A_INST_BFT_II INNOVANCE PFA-200 System IVDR_27_MAR EB_A_INST_INN_PFA-200	A IVDR	EUDAMED record Report an error
Standard heparin	W0103020303	INNOVANCE Anti-Xa IVDR_27_MAR EB_C_KIT_INN_A-Xa2 refs INNOVANCE Heparin IVDR_27_MAR EB_C_KIT_INN_Hep2 refs	C IVDR	EUDAMED record Report an error
A2-antiplasmin	W0103020501	Berichrom a2-Antiplasmin IVDR_27_MAR EB_B_KIT_Ber_a2-Antipl3 refs	B IVDR	EUDAMED record Report an error
Aggregation reagents	W0103020401	Dade PFA Collagen/ADP Test Cartridge IVDR_27_MAR EB_B_REAG_PFA_Coll_ADP_EPI2 refs	B IVDR	EUDAMED record Report an error
Automated coagulometers	W0202020102	BCS XP System IVDR_27_MAR EB_A_INST_BCS_XP	A IVDR	EUDAMED record Report an error
Automated immunochemistry analysers - moderate routine (throughput > 100 and <= 250 test/h)	W0201020102	IMMULITE® 2000 XPi Immunoassay System IVDR_67_LLB_DUB-C_A_INST_XPi	A IVDR	EUDAMED record Report an error
Automated slide stainers	W0202059002	Hematek 3000 System IVDR_27_MAR EB_A_INST_Hematek_3000	A IVDR	EUDAMED record Report an error
Auxiliary reagents (haemostasis) - other	W0103020999	Kaolin Suspension IVDR_27_MAR EB_A_REAG_Kaolin2 refs	A IVDR	EUDAMED record Report an error
Calcium chloride	W0103020901	Calcium Chloride Solution IVDR_27_MAR EB_A_PROF_REAG_CaCl23 refs	A IVDR	EUDAMED record Report an error
Chemistry analysers - hardware accessories	W0201010180	VersaCell X3 Solution IVDR_27_LLB_DUB-C_A_INST_VersaCell X3	A IVDR	EUDAMED record Report an error
Cmv igg	W0105040203	IMMULITE 2000 CMV IgG IVDR_67_LLB_DUB-C_C_REAG_KIT_CMV IgG	C IVDR	EUDAMED record Report an error
Cmv igm	W0105040204	IMMULITE 2000 CMV IgM IVDR_67_LLB_DUB-C_C_KIT_CMV IgM	C IVDR	EUDAMED record Report an error
Coagulation factor II ( prothrombin )	W0103020202	Coagulation Factor II Deficient Plasma IVDR_27_MAR EB_B_REAG_FII_Def_Pl3 refs	B IVDR	EUDAMED record Report an error
Coagulation factor ix	W0103020208	Coagulation Factor IX Deficient Plasma IVDR_27_MAR EB_C_PROF_REAG_FIX_Def_Pl3 refs	C IVDR	EUDAMED record Report an error
Coagulation factor v	W0103020204	Coagulation Factor V Deficient Plasma IVDR_27_MAR EB_B_REAG_FV_Def_Pl3 refs	B IVDR	EUDAMED record Report an error
Coagulation factor vii	W0103020205	Coagulation Factor VII Deficient Plasma IVDR_27_MAR EB_C_REAG_FVII_Def_Pl3 refs	C IVDR	EUDAMED record Report an error
Coagulation factor X	W0103020209	Coagulation Factor X Deficient Plasma IVDR_27_MAR EB_C_REAG_FX_Def_Pl3 refs	C IVDR	EUDAMED record Report an error
Coagulation factor xi	W0103020210	Coagulation Factor XI Deficient Plasma IVDR_27_MAR EB_B_PROF_REAG_FXI_Def_Pl3 refs	B IVDR	EUDAMED record Report an error
Coagulation factor xii	W0103020211	Coagulation Factor XII Deficient Plasma IVDR_27_MAR EB_B_PROF_REAG_FXII_Def_Pl3 refs	B IVDR	EUDAMED record Report an error
Coagulation factor xiii	W0103020213	Berichrom F XIII IVDR_27_MAR EB_C_KIT_Ber_FXIII2 refs	C IVDR	EUDAMED record Report an error
Ebv ebna igg	W010504040106	IMMULITE 2000 EBV-EBNA IgG IVDR_67_LLB_DUB-C_B_KIT_EBV-EBNA IgG	B IVDR	EUDAMED record Report an error
Ebv vca igg	W010504040105	IMMULITE 2000 EBV-VCA IgG IVDR_67_LLB_DUB-C_B_KIT_EBV-VCA IgG	B IVDR	EUDAMED record Report an error
Ebv vca igm	W010504040104	IMMULITE 2000 EBV-VCA IgM IVDR_67_LLB_DUB-C_B_KIT_EBV-VCA IgM	B IVDR	EUDAMED record Report an error
H. pylori antibody assays	W0105010402	IMMULITE 2000 H. pylori IgG IVDR_67_LLB_DUB-C_B_KIT_H. pylori IgG2 refs	B IVDR	EUDAMED record Report an error
Hepatitis b core antibody (total)	W0105020208	ADVIA Centaur HBc Total 2 (HBcT2) IVDR_67_LLB_DUB-C_D_KIT_HBc Total 22 refs	D IVDR	EUDAMED record Report an error
Hepatitis b core antibody igm	W0105020210	IMMULITE 2000 Anti-HBc IgM DX LS_LEGACY_0063041496172998/79	– 98/79	EUDAMED record Report an error
Hepatitis b core antigen	W0105020206	IMMULITE 2000 Anti-HBc IVDR_67_LLB_DUB-C_D_KIT_Anti-HBc	D IVDR	EUDAMED record Report an error
Hepatitis b surface antigen - confirmatory	W0105020202	IMMULITE 2000 HBsAg Confirmatory Kit DX LS_LEGACY_0063041498217598/79	– 98/79	EUDAMED record Report an error
Hsv 1+2 igg	W0105040303	IMMULITE 2000 Herpes I & II IgG IVDR_67_LLB_DUB-C_C_KIT_Herpes I & II IgG	C IVDR	EUDAMED record Report an error
Interferons (α, β, ɣ…)	W01030601	IMMULITE 2000 IL-1β IVDR_67_LLB_DUB-C_B_KIT_IL-1β	B IVDR	EUDAMED record Report an error
Interleukin 6 (il-6)	W01030609	IMMULITE 2000 IL-6 IVDR_67_LLB_DUB-C_B_KIT_IL-6	B IVDR	EUDAMED record Report an error
Interleukins receptors (il-2r,il6r ...)	W01030607	IMMULITE 2000 IL2R IVDR_67_LLB_DUB-C_B_KIT_IL2R	B IVDR	EUDAMED record Report an error
Lupus anticoagulant	W0103020606	LA 1 Screening Reagent IVDR_27_MAR EB_B_REAG_LA1/23 refs	B IVDR	EUDAMED record Report an error
P2y12 receptor	W0103020407	INNOVANCE PFA P2Y IVDR_27_MAR EB_B_REAG _INN_PFA_P2Y	B IVDR	EUDAMED record Report an error
Parasitology controls - inf.imm.	W0105080805	IMMULITE Toxoplasma IgG Control Module IVDR_67_LLB_DUB-C_C_REAG_Toxoplasma IgG Control Module	C IVDR	EUDAMED record Report an error
Primary hemostasis/platelet factors - other	W0103020499	Dade PFA Trigger Solution IVDR_27_MAR EB_A_REAG_PFA_TrigSol	A IVDR	EUDAMED record Report an error
Protein c	W0103020607	Berichrom Protein C IVDR_27_MAR EB_C_KIT_Ber_Prot_C3 refs	C IVDR	EUDAMED record Report an error
Prothrombin fragment 1 + 2	W0103020306	Enzygnost F1+2 monoclonal IVDR_27_MAR EB_C_KIT_Enz_F1+2_mono	C IVDR	EUDAMED record Report an error
Rubella virus igg	W0105040102	IMMULITE 2000 Rubella Quantitative IgG IVDR_67_LLB_DUB-C_C_REAG_KIT_Rubella Quantitative IgG2 refs	C IVDR	EUDAMED record Report an error
Rubella virus igm	W0105040103	IMMULITE 2000 Rubella IgM IVDR_67_LLB_DUB-C_C_KIT_Rubella IgM	C IVDR	EUDAMED record Report an error
Soluble antigens / receptors	W01030602	IMMULITE 2000 IL-8 IVDR_67_LLB_DUB-C_B_KIT_IL-8	B IVDR	EUDAMED record Report an error
Special coagulation tests - other	W0103020399	INNOVANCE DTI Assay IVDR_27_MAR EB_C_KIT_INN_DTI2 refs	C IVDR	EUDAMED record Report an error
Syphilis antigen detection	W0105010301	IMMULITE 2000 Syphilis Screen IVDR_67_LLB_DUB-C_C_KIT_Syphilis Screen2 refs	C IVDR	EUDAMED record Report an error
Thrombin-antithrombin III-complex	W0103020307	Enzygnost TAT micro IVDR_27_MAR EB_C_KIT_Enz_TAT_mic	C IVDR	EUDAMED record Report an error
Toxoplasma antibody igg	W0105050102	IMMULITE 2000 Toxoplasma Quantitative IgG IVDR_67_LLB_DUB-C_C_KIT_Toxoplasma Quantitative IgG	C IVDR	EUDAMED record Report an error
Toxoplasma antibody igm	W0105050103	IMMULITE 2000 Toxoplasma IgM (µ-Capture) IVDR_67_LLB_DUB-C_C_KIT_Toxoplasma IgM	C IVDR	EUDAMED record Report an error
Tumour necrosis factors (tnfα,tnfβ, ...)	W01030603	IMMULITE 2000 TNFα IVDR_67_LLB_DUB-C_B_KIT_TNFα	B IVDR	EUDAMED record Report an error
Tumour necrosis factors receptors (tnf-r i,tnf-r II)	W01030604	IMMULITE 2000 IL-10 IVDR_67_LLB_DUB-C_B_KIT_IL-10	B IVDR	EUDAMED record Report an error
Various general purpose IVD instruments - software accessories	W02079082	PRISCA 5 Prenatal Risk Calculation Software DX_LS_LEGACY_0063041402305298/79	– 98/79	EUDAMED record Report an error

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