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Siemens Healthcare Diagnostics

États-UnisEntités : Siemens Healthcare Diagnostics Inc.

Marchés : Allemagne · Autriche · Belgique · États-Unis

Autorisations : UE – classe A, B, C, D · États-Unis (FDA) – 510(k) : 246 · PMA : 19 · classe I, II, III · dernière en 2026 · voir sur le site de la FDA

Marchés publics remportés : Autriche 72

Mandataire UE : Siemens Healthcare Diagnostics Manufacturing Limited (Irlande)

Site web contact@siemens-healthineers.com

62 catégories, 202 modèles dont 202 en vente, 1 pays

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93/42 Ancienne directive, pas encore certifié selon le règlement MDR
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Catégorie	Code EMDN	Modèles enregistrés	Classe	Contact
Chemistry analysers - consumables	W0201010185	ADVIA Chemistry Systems 20-mL Wedges IVDR_67_TTN_DUB-C_A_INST_Wedges3 réf. ADVIA Chemistry Systems Sample Cup IVDR_67_TTN_DUB-C_A_INST_Sam Cup ADVIA Chemistry XPT Cuvette Detergent IVDR_67_TTN_DUB-C_A_REAG_XPT Cuvette Detergent ADVIA Chemistry XPT Probe Wash 0 IVDR_67_TTN_DUB-C_A_REAG_XPT Probe Wash 0 ADVIA® Chemistry Cuvette Conditioner IVDR_67_TTN_DUB-C_A_REAG_Cuvette Conditioner 32 autres ADVIA® Chemistry Cuvette Wash Solution IVDR_67_TTN_DUB-C_A_REAG_Cuvette Wash Solution ADVIA® Chemistry Reagent Probe Wash 1 IVDR_67_TTN_DUB-C_A_REAG_Reagent Probe Wash 1 ADVIA® Chemistry Reagent Probe Wash 2 IVDR_67_TTN_DUB-C_A_REAG_Reagent Probe Wash 2 ADVIA® Chemistry Reagent Probe Wash 3 IVDR_67_TTN_DUB-C_A_REAG_Reagent Probe Wash 3 Atellica CH Check Reagent (CHK) IVDR_67_TTN_DUB-C_A_REAG_Check Reagent Atellica CH Cleaner IVDR_67_TTN_DUB-C_A_REAG_Cleaner Atellica CH Conditioner IVDR_67_TTN_DUB-C_A_REAG_Conditioner Atellica CH EMPTY IVDR_67_TTN_DUB-C_A_INST_EMPTY3 réf. Atellica CH Lamp Coolant (LC) IVDR_67_TTN_DUB-C_A_REAG_Lamp Coolant Atellica CH Reagent Probe Cleaner 1 (RPC1) IVDR_67_TTN_DUB-C_A_REAG_Reagent Probe Cleaner 1 Atellica CH Reagent Probe Cleaner 2 (RPC2) IVDR_67_TTN_DUB-C_A_REAG_Reagent Probe Cleaner 2 Atellica CH Reagent Probe Cleaner 4 (RPC4) IVDR_67_TTN_DUB-C_A_REAG_Reagent Probe Cleaner 4 Atellica CH Wash IVDR_67_TTN_DUB-C_A_REAG_Wash Atellica CH Water Bath Additive (WBA) IVDR_67_TTN_DUB-C_A_REAG_Water Bath Additive Atellica HA1C_E High Volume Bottles (5) IVDR_67_TTN_DUB-C_A_KIT_HIGH VOLUME BOTTLE KIT Atellica HA1C_E High Volume Conversion Kit IVDR_67_TTN_DUB-C_A_KIT_HA1C_E HIGH VOLUME CONVERSION KIT Atellica HA1C_E High Volume Labels (50) IVDR_67_TTN_DUB-C_A_KIT_HIGH VOLUME LABEL KIT Atellica HEMA Cleaner IVDR_27_TTN_DUB-C_A_REAG_Cleaner Atellica HEMA Decon IVDR_27_TTN_DUB-C_A_REAG_Decon Atellica Lid Keying Feature IVDR_67_TTN_DUB-C_A_KIT_LID KEYING FEATURE KIT Dimension CHK Flex reagent cartridge IVDR_67_GLA_DUB-C_A_REAG_CHK2 réf. Dimension Vista Barcode Labels IVDR_67_GLA_DUB-C_A_INST_Barcode Labels Dimension Vista Cuvette Wash Solution IVDR_67_GLA_DUB-C_A_REAG_Cuvette Wash Solution Dimension Vista Cuvette Waste Container Liner IVDR_67_GLA_DUB-C_A_INST_Waste A Liner Dimension Vista Cuvette Waste Container Liner IVDR_67_GLA_DUB-C_A_INST_Waste B Liner Dimension Vista Cuvettes (CUV) IVDR_67_GLA_DUB-C_A_INST_CUV Dimension Vista Empty Flex reagent cartridge IVDR_67_GLA_DUB-C_A_INST_Empty Flex reagent cartridge Dimension Vista Reagent Probe Cleaner IVDR_67_GLA_DUB-C_A_REAG_Reagent Probe Cleaner2 réf. Dimension Vista Sample Probe Cleaner IVDR_67_GLA_DUB-C_A_REAG_Small Probe Cleaner Dimension Vista® Aliquot Plates IVDR_67_GLA_DUB-C_A_INST_Aliquot Plates Dimension Vista® Empty Vials Kit IVDR_67_GLA_DUB-C_A_INST_Empty Vials Kit Dimension® Aliquot Wheel Assembly IVDR_67_GLA_DUB-C_A_INST_Aliquot Wheel Assembly	A IVDR	Fiche EUDAMED Signaler une erreur
Cbc-reagents (cleaning-/diluting-/lysing-/sheath-fluids)	W0103010105	ADVIA 120/2120/2120i® CN-FREE CBC TIMEPAC IVDR_67_TTN_DUB-C_A_INST_CN-Free CBC TIMEPAC ADVIA 120/2120/2120i® Defoamer IVDR_67_TTN_DUB-C_A_REAG_Defoamer ADVIA 120/2120/2120i® DIFF TIMEpac IVDR_67_TTN_DUB-C_A_REAG_DIFF TIMEPAC ADVIA 120/2120/2120i® Perox Sheath IVDR_67_TTN_DUB-C_A_REAG_PEROX SHEATH ADVIA 120/2120/2120i® Sheath/Rinse IVDR_67_TTN_DUB-C_A_REAG_Sheath/Rinse2 réf. 15 autres ADVIA 2120 and ADVIA 2120i Aspiration Pathway Wash IVDR_67_TTN_DUB-C_A_KIT_Aspiration Pathway Wash Kit ADVIA 2120 and ADVIA 2120i Perox Flow Cell Wash IVDR_67_TTN_DUB-C_A_REAG_Perox Flow Cell Wash Kit ADVIA 2120 and ADVIA 2120i RBC Flow Cell Wash IVDR_67_TTN_DUB-C_A_REAG_RBC Flow Cell Wash Kit ADVIA 2120 and ADVIA 2120i Vent Line Wash IVDR_67_TTN_DUB-C_A_INST_Vent Line Wash Reagent ADVIA 360 Cleaner IVDR_67_TTN_DUB-C_A_REAG_360 Cleaner ADVIA 360/560 Dil IVDR_67_TTN_DUB-C_A_REAG_Dil ADVIA 360/560 Hypoclean CC IVDR_67_TTN_DUB-C_A_REAG_Hypoclean CC ADVIA 360/560 Hypoclean IVDR_67_TTN_DUB-C_A_REAG_Hypoclean ADVIA 560 5P Diff IVDR_67_TTN_DUB-C_A_REAG_5P Diff ADVIA ® 120/2120/2120i EZ WASH IVDR_67_TTN_DUB-C_A_REAG_EZ Wash ADVIA® 120/2120/2120i CBC TIMEpac IVDR_67_TTN_DUB-C_A_REAG_CBC TIMEPAC ADVIA® 360 Lyse 3P Diff IVDR_67_TTN_DUB-C_A_REAG_Lyse 3P Diff ADVIA® 560 Lyse IVDR_67_TTN_DUB-C_A_REAG_Lyse ADVIA® Autoslide Rinse IVDR_67_TTN_DUB-C_A_REAG_Autoslide Rinse Atellica HEMA WBC DIFF IVDR_27_TTN_DUB-C_A_REAG_HEMA WBC Diff	A IVDR	Fiche EUDAMED Signaler une erreur
Automated immunochemistry analysers - consumables	W0201020185	ADVIA Centaur Sample Cups, 1500/Pkg IVDR_67_TTN_DUB-C_A_INST_S Cups Atellica Solution Tube Top Sample Cup 1mL IVDR_67_TTN_DUB-C_A_INST_Tube Top Sample Cup2 réf. Dimension EMPTY Flex Reagent Cartridge IVDR_67_GLA_DUB-C_A_INST_EMPTY Dimension Sample Cups IVDR_67_GLA_DUB-C_A_INST_Sam Cups Dimension Sample Transfer Module Aliquot Segment IVDR_67_GLA_DUB-C_A_INST_Sample Transfer Mod Aliquot Segment 9 autres Dimension Sample Transfer Module Pipette Tips IVDR_67_GLA_DUB-C_A_INST_Sample Transfer Module Pipette Tips Dimension Vista LOCI Reaction Vessel IVDR_67_GLA_DUB-C_A_INST_LOCI Reaction Vessel Dimension XL/RxL Printer Paper IVDR_67_GLA_DUB-C_A_INST_Printed paper Dimension® Chemistry Wash IVDR_67_GLA_DUB-C_A_REAG_Chem Wash Dimension® Cuvette Cartridge IVDR_67_GLA_DUB-C_A_INST_Cuvette Cartridge Dimension® Reaction Vessels IVDR_67_GLA_DUB-C_A_INST_Reaction Vessels Dimension® Sample Probe Cleaner IVDR_67_GLA_DUB-C_A_REAG_Sample Probe Cleaner Dimension® Small Sample Container (SSC) IVDR_67_GLA_DUB-C_A_INST_SSC EZEE-NEST 13-mm Sample Cups IVDR_67_TTN_DUB-C_A_INST_Ez SCup2 réf.	A IVDR	Fiche EUDAMED Signaler une erreur
Hepatitis virus controls - inf.imm.	W0105080802	ADVIA Centaur Anti-HBs2 (aHBs2) Quality Control IVDR_67_TTN_DUB-C_D_REAG_Anti-HBs2 QC2 réf. ADVIA Centaur HAV IgM (aHAVM) Quality Control IVDR_67_TTN_DUB-C_B_REAG_aHAVM_QC2 réf. ADVIA Centaur HAV Total (aHAVT) Quality Control IVDR_67_TTN_DUB-C_B_REAG_aHAVT_QC2 réf. ADVIA Centaur HBc IgM (aHBcM) Quality Control IVDR_67_TTN_DUB-C_D_REAG_aHBcM QC2 réf. ADVIA Centaur HBeAg (HBe) Quality Control IVDR_67_TTN_DUB-C_D_REAG_Hepatitis B e Antigen QC2 réf. 2 autres ADVIA Centaur HBsAg Quality Control Material IVDR_67_TTN_DUB-C_D_REAG_HBsAg Quality Control2 réf. ADVIA Centaur HCV Quality Control IVDR_67_TTN_DUB-C_D_REAG_aHCV QC2 réf.	B, D IVDR	Fiche EUDAMED Signaler une erreur
Blood gas analysers - consumables	W0201040185	100 Mixing Fleas + Magnet IVDR_69_TTN_DUB-C_A_NPT_MultiCaps3 réf. Deproteinizer IVDR_69_TTN_DUB-C_A_NPT_REAG_BG-RL1200/348EX_CP2 réf. Luer Capillary IVDR_69_TTN_DUB-C_A_NPT_BG-RapidLab12003 réf. RAPIDChem 744/754 Printer Paper IVDR_69_TTN_DUB-C_A_BG-RapidChem RAPIDPoint® 500 Systems Wash/Waste Cartridge IVDR_69_TTN_DUB-C_A_NPT_REAG_BG-RapidPoint2 réf. 1 autre TB2 pH/NA Test/Blank Sensor IVDR_69_TTN_DUB-C_A_NPT_REAG_BG-RL1200/348EX3 réf.	A IVDR	Fiche EUDAMED Signaler une erreur
Haematology controls - other	W0103010599	ADVIA 120/2120/2120i 3 in 1 TESTpoint CSF Controls IVDR_67_TTN_DUB-C_B_REAG_CSF Controls ADVIA 120/2120/2120i TESTpoint Hematology Controls (High) IVDR_67_TTN_DUB-C_B_REAG_Control High ADVIA 120/2120/2120i TESTpoint Hematology Controls (Low) IVDR_67_TTN_DUB-C_B_REAG_Control Low ADVIA 360 Control IVDR_67_TTN_DUB-C_B_REAG_Control2 réf. Atellica HEMA Control BF (H) DX LS_LEGACY_0063041429012698/79 1 autre Atellica HEMA Control BF (N) DX LS_LEGACY_0063041429011998/79	B IVDR, 98/79	Fiche EUDAMED Signaler une erreur
Other virology controls - inf.imm.	W0105080804	ADVIA Centaur Herpes-1 IgG (HSV1) Quality Control IVDR_67_TTN_DUB-C_C_REAG_HSV1 QC2 réf. ADVIA Centaur Herpes-2 IgG (HSV2) Quality Control IVDR_67_TTN_DUB-C_C_REAG_HSV2 QC2 réf. ADVIA Centaur Rub G quality control material IVDR_67_TTN_DUB-C_C_REAG_Rub G QC2 réf. ADVIA Centaur Rub M quality control material IVDR_67_TTN_DUB-C_C_REAG_Rubella M Quality Control Material2 réf. ADVIA Centaur Toxo G Quality Control Material IVDR_67_TTN_DUB-C_C_REAG_ToxoG_QC2 réf. 1 autre ADVIA Centaur Toxo M Quality Control Material IVDR_67_TTN_DUB-C_C_REAG_Toxo M QC2 réf.	C IVDR	Fiche EUDAMED Signaler une erreur
Chemistry analysers - hardware accessories	W0201010180	Atellica CH Dilution Cuvette Segment IVDR_67_TTN_DUB-C_A_INST_Dilution Cuvette Segment2 réf. Atellica CH Reaction Cuvette Segment IVDR_67_TTN_DUB-C_A_INST_Reaction Cuvette Segment2 réf. Atellica DL IVDR_67_TTN_DUB-C_A_INST_DL Atellica SH Additional IVDR_67_TTN_DUB-C_A_INST_Additional Atellica SH Prime IVDR_67_TTN_DUB-C_A_INST_Prime2 réf.	A IVDR	Fiche EUDAMED Signaler une erreur
Abnormal blood controls	W0103010502	ADVIA 120/2120/2120i 3•in•1 TESTpoint Hematology Controls (ABN1 Control) IVDR_67_TTN_DUB-C_B_REAG_TESTpt 3-in -1 Control Abnor 1 ADVIA 120/2120/2120i 3•in•1 TESTpoint Hematology Controls (ABN2 Control) IVDR_67_TTN_DUB-C_B_REAG_TESTpoint 3-in-1 Con Abnor 2 Atellica HEMA Control (H) DX LS_LEGACY_0063041429007298/79 Atellica HEMA Control (L) DX LS_LEGACY_0063041429005898/79	B IVDR, 98/79	Fiche EUDAMED Signaler une erreur
Chemistry analysers - low routine (with ise mode test/h <= 400)	W0201010105	ADVIA Centaur XPT Immunoassay System IVDR_67_TTN_DUB-C_A_INST_ADVIA Centaur XPT ADVIA Centaur® CP Immunoassay System IVDR_67_TTN_DUB-C_A_INST_CP Immunoassay System Dimension® EXL™ 200 Integrated Chemistry System IVDR_67_GLA_DUB-C_A_INST_EXL 200 integrated chemistry system Dimension® EXL™ with LM Integrated Chemistry System IVDR_67_GLA_DUB-C_A_INST_EXL 200 w/LM integrated chem system	A IVDR	Fiche EUDAMED Signaler une erreur
Controls - inf. immunology - other	W0105080899	ADVIA Centaur Zika Ab Quality Control DX_LS_LEGACY_0063041424703898/79 ADVIA Centaur Zika IgM Quality Control DX_LS_LEGACY_0063041424701498/79 Atellica IM Zika Ab Quality Control DX_LS_LEGACY_0063041428686098/79 Atellica IM Zika IgM Quality Control DX_LS_LEGACY_0063041428684698/79	– 98/79	Fiche EUDAMED Signaler une erreur
Reticulocyte controls	W0103010506	ADVIA 120/2120/2120i TESTpoint Reticulocyte Controls (High) IVDR_67_TTN_DUB-C_B_REAG_Reticulocyte Control High2 réf. Atellica HEMA Control RETIC (H) DX LS_LEGACY_0063041429010298/79 Atellica HEMA Control RETIC (L) DX LS_LEGACY_0063041429008998/79 Atellica HEMA Control RETIC (N) DX LS_LEGACY_0063041429009698/79	B IVDR, 98/79	Fiche EUDAMED Signaler une erreur
Romanowsky stains	W0103010302	ADVIA Autoslide Modified Wright Stain IVDR_67_TTN_DUB-C_A_REAG_A.slide Modified Wright's Stn ADVIA® Autoslide Wright Giemsa Stain IVDR_67_TTN_DUB-C_A_REAG_Autoslide Wright Giemsa Stain Hematek Stain Pak – Modified Wright’s Stain IVDR_67_TTN_DUB-C_A_REAG_Hematek Modified Wright Stain Pak Hematek Stain Pak – Wright-Giemsa Stain IVDR_67_TTN_DUB-C_A_REAG_Hematek Modified W.Giemsa Stain Pak	A IVDR	Fiche EUDAMED Signaler une erreur
Whole blood calibrators	W0103010507	ADVIA 120/2120/2120i OPTIpoint IVDR_67_TTN_DUB-C_B_REAG_OPTIpoint ADVIA 120/2120/2120i SETpoint Calibrator IVDR_67_TTN_DUB-C_B_REAG_SETpoint Calibrator ADVIA 360/560 Calibrator IVDR_67_TTN_DUB-C_B_REAG_Calibrator Atellica HEMA Calibrator DX LS_LEGACY_0063041428720198/79	B IVDR, 98/79	Fiche EUDAMED Signaler une erreur
Zika virus - NA reagents	W0105040531	ADVIA Centaur Zika Ab DX_LS_LEGACY_0063041424702198/79 ADVIA Centaur Zika IgM DX_LS_LEGACY_0063041424700798/79 Atellica IM Zika Ab DX_LS_LEGACY_0063041428685398/79 Atellica IM Zika IgM DX_LS_LEGACY_0063041428683998/79	– 98/79	Fiche EUDAMED Signaler une erreur
Automated urine analysers	W020101020103	CLINITEK Advantus Analyzer IVDR_69_TTN_DUB-C_A_NPT_INST_De-Centralized Urin Adv CLINITEK Novus® Automated Urine Chemistry Analyzer IVDR_69_TTN_DUB-C_A_INST_Centralized Urin Novus2 réf. CLINITEK Status+ Analyzer IVDR_69_TTN_DUB-C_A_NPT_INST_De-Centralized Urin Stat3 réf.	A IVDR	Fiche EUDAMED Signaler une erreur
Automated urine analysers - consumables	W020101020185	Atellica LumIQ Module IVDR_69_TTN_DUB-C_A_NPT_INST_De-Cent. Urine LumIQ Analyzer3 réf. CLINITEK Novus PRO 12 Urinalysis Cassette IVDR_69_TTN_DUB-C_B_REAG_PROT_MICR_Centralized Urin Novus2 réf. CLINITEK Status Connector (WW WiFi) IVDR_69_TTN_DUB-C_A_NPT_De-Centralized Urin Stat2 réf.	A, B IVDR	Fiche EUDAMED Signaler une erreur
Automated whole blood hematology analysers - hardware accessories	W0202010180	ADVIA Autoslide Slide Maker Stainer (SMS) Assembly IVDR_67_TTN_DUB-C_A_INST_Autoslide SMS Assembly Atellica HEMA Slidemaker Stainer (SMS) IVDR_27_TTN_DUB-C_A_INST_SMS Atellica HEMA TRANS. ASSY RIGHT MODULE INST Only IVDR_27_TTN_DUB-C_A_INST_RIGHT MODULE INST ONLY	A IVDR	Fiche EUDAMED Signaler une erreur
Automated whole blood hematology analysers - moderate routine (throughput > 100 and <= 120 samples/hr)	W0202010102	ADVIA 2120i with DAA Autosampler IVDR_67_TTN_DUB-C_B_Inst_Sample Rack3 réf. ADVIA 2120i with SAA Autosampler DX_LS_LEGACY_0063041401978998/79 ADVIA 2120i without Autosampler IVDR_67_TTN_DUB-C_B_Inst _No Sample Rack	B IVDR, 98/79	Fiche EUDAMED Signaler une erreur
Hepatitis b antigen	W0105020211	ADVIA Centaur Anti-HBe2 (aHBe2) IVDR_67_TTN_DUB-C_D_REAG_KIT_aHBe22 réf. ADVIA Centaur Anti-HBe2 Quality Control (aHBe2 QC) IVDR_67_TTN_DUB-C_D_REAG_KIT_aHBe2 QC2 réf. ADVIA Centaur Hepatitis B e Antigen IVDR_67_TTN_DUB-C_D_KIT_HBeAg2 réf.	D IVDR	Fiche EUDAMED Signaler une erreur
Hepatitis b surface antigen	W0105020201	ADVIA Centaur anti-HBs2 IVDR_67_TTN_DUB-C_D_KIT_Anti-HBs22 réf. ADVIA Centaur HBsAgII IVDR_67_TTN_DUB-C_D_KIT_HBsAgII3 réf. ADVIA Centaur® HBc IgM IVDR_67_TTN_DUB-C_D_KIT_aHBcM2 réf.	D IVDR	Fiche EUDAMED Signaler une erreur
Histo / cyto stains	W0103010301	ADVIA Autoslide Giemsa Stain IVDR_67_TTN_DUB-C_A_INST_Autoslide Giemsa Stain ADVIA Autoslide May-Grünwald Giemsa Buffer IVDR_67_TTN_DUB-C_A_REAG_A.slide May-Grünwald Gie Buff ADVIA Autoslide May-Grünwald Stain IVDR_67_TTN_DUB-C_A_INST_AutoSlide May-Grunwald Stain	A IVDR	Fiche EUDAMED Signaler une erreur
IVD general use consumable devices - other	W0599	ADVIA Centaur Disposable Sample Tips IVDR_67_TTN_DUB-C_A_INST_Sample Probe Tip ADVIA Centaur Systems Cuvette IVDR_67_TTN_DUB-C_A_INST_Cuvette Dimension Vista® Small Sample Container (SSC) IVDR_67_GLA_DUB-C_A_INST_Small Sample Container	A IVDR	Fiche EUDAMED Signaler une erreur
Normal blood controls	W0103010501	ADVIA 120/2120/2120i 3•in•1 TESTpoint Hematology Controls (Norm Control) IVDR_67_TTN_DUB-C_B_REAG_TESTpoint 3-in -1 Con Normal ADVIA 120/2120/2120i TESTpoint Hematology Controls (Norm) IVDR_67_TTN_DUB-C_B_REAG_Control Normal Atellica HEMA Control (N) DX LS_LEGACY_0063041429006598/79	B IVDR, 98/79	Fiche EUDAMED Signaler une erreur
Various hematology / histology / cytology instruments - hardware accessories	W02029080	Atellica HEMA TRANS. RIGHT MODULE 1 INST IVDR_27_TTN_DUB-C_A_INST_RIGHT MODULE 1 INST Atellica HEMA TRANS. RIGHT MODULE 2 INST IVDR_27_TTN_DUB-C_A_INST_RIGHT MODULE 2 INST Atellica HEMA TRANS. RIGHT MODULE SPS ONLY IVDR_27_TTN_DUB-C_A_INST_RIGHT MODULE SPS ONLY	A IVDR	Fiche EUDAMED Signaler une erreur
Automated sample transport systems	W02060102	ADVIA Autoloader IVDR_67_TTN_DUB-C_A_INST_Autoloader IVDR_67_TTN_DUB-C_A_INST_Atellica Rack Handler	A IVDR	Fiche EUDAMED Signaler une erreur
Bacteriology controls - inf.imm.	W0105080801	ADVIA Centaur Syphilis Quality Control Material DX LS_LEGACY_0063041458061698/79 Atellica IM Syphilis Quality Control (Syph QC) DX LS_LEGACY_0063041459989298/79	– 98/79	Fiche EUDAMED Signaler une erreur
Cmv igm	W0105040204	ADVIA Centaur CMV IgM (CMV IgM) IVDR_67_TTN_DUB-C_C_REAG_KIT_CMV IgM2 réf. ADVIA Centaur CMV IgM Quality Control (CMV IgM QC) IVDR_67_TTN_DUB-C_C_REAG_CMV IgM QC2 réf.	C IVDR	Fiche EUDAMED Signaler une erreur
Fixing reagents (histology/cytology)	W01030705	ADVIA Autoslide Modified Wright Buffer IVDR_67_TTN_DUB-C_A_REAG_A.slide Modified Wright's Buff ADVIA Autoslide Wright Giemsa Buffer IVDR_67_TTN_DUB-C_A_REAG_Autoslide Wright Giemsa Buffer	A IVDR	Fiche EUDAMED Signaler une erreur
Interleukin 6 (il-6)	W01030609	ADVIA Centaur Interleukin-6 (IL6) assay DX_LS_LEGACY_0063041401043498/79 Atellica IM Interleukin-6 (IL6) IVDR_67_TTN_DUB-C_A_KIT_Interleukin-6	B IVDR, 98/79	Fiche EUDAMED Signaler une erreur
Lymphokines /immunmodulators - other	W01030699	ADVIA Centaur Interleukin-6 (IL6) Quality Control DX_LS_LEGACY_0063041401047298/79 Atellica IM Interleukin-6 Quality Control (IL6 QC) IVDR_67_TTN_DUB-C_B_REAG_Interleukin-6 QC Material	B IVDR, 98/79	Fiche EUDAMED Signaler une erreur
Automated immunochemistry analysers - moderate routine (throughput > 100 and <= 250 test/h)	W0201020102	Atellica IM 1300 Analyzer IVDR_67_TTN_DUB-C_A_INST_1300 Analyzer2 réf.	A IVDR	Fiche EUDAMED Signaler une erreur
Automated immunochemistry analysers - moderate to high routine (throughput > 250 and <= 700 test/h)	W0201020103	Atellica IM 1600 Analyzer IVDR_67_TTN_DUB-C_A_INST_1600 Analyzer2 réf.	A IVDR	Fiche EUDAMED Signaler une erreur
Automated slide stainers	W0202059002	ADVIA Autoslide® Slide Maker Stainer IVDR_67_TTN_DUB-C_A_INST_Autoslide Slide Maker Stainer	A IVDR	Fiche EUDAMED Signaler une erreur
Automated systems for the management of pre and post-analysis	W02060101	Atellica Direct Connect for CI IVDR_67_TTN_DUB-C_A_INST_ATELLICA CI DIRECT CONNECT	A IVDR	Fiche EUDAMED Signaler une erreur
Automated whole blood hematology analysers - low routine (throughput <= 100 samples/hr)	W0202010101	ADVIA 360 Hematology System IVDR_67_TTN_DUB-C_B_INST_Hematology System2 réf.	B IVDR	Fiche EUDAMED Signaler une erreur
Bag sealers	W02029010	Atellica IM Ancillary Seal Kit IVDR_67_TTN_DUB-C_A_KIT_Ancillary Seal Kit	A IVDR	Fiche EUDAMED Signaler une erreur
Blood gas analysers - hardware accessories	W0201040180	RAPIDPoint 500 Blood Gas Analyzer IVDR_69_TTN_DUB-C_A_NPT_INST_BG-RapidPoint3 réf.	A IVDR	Fiche EUDAMED Signaler une erreur
BLOOD GAS ANALYSERS - WITH ADDITIONAL PARAMETERS (pH, pO2, pCO2, Hct + metabolites + electrolytes, CO-oximeter parameters and coagulation parameters)	W0201040102	RAPIDLab® 1240 Blood Gas Analyzer IVDR_69_TTN_DUB-C_A_NPT_INST_BG-RapidLab12003 réf.	A IVDR	Fiche EUDAMED Signaler une erreur
Blood gas analysers - with classic profile (pH, PO2, PCO2, hct + electrolytes)	W0201040101	RAPIDLab 348EX System IVDR_69_TTN_DUB-C_A_NPT_INST_BG-348EX2 réf.	A IVDR	Fiche EUDAMED Signaler une erreur
Cardiac marker portable analysers	W0201069001	Atellica VTLi Docking Station IVDR_69_TTN_DUB-C_A_NPT_VTLi-DS	A IVDR	Fiche EUDAMED Signaler une erreur
Chemistry analysers - moderate to high routine (with ise mode test/h > 800 and <= 1.200)	W0201010107	Atellica CH 930 Analyzer IVDR_67_TTN_DUB-C_A_INST_930 Analyzer2 réf.	A IVDR	Fiche EUDAMED Signaler une erreur
Hav antibody (total)	W0105020102	ADVIA Centaur aHAVT assay IVDR_67_TTN_DUB-C_B_KIT_aHAVT2 réf.	B IVDR	Fiche EUDAMED Signaler une erreur
Hav antibody igm	W0105020104	ADVIA Centaur® HAV IgM IVDR_67_TTN_DUB-C_B_KIT_aHAVM2 réf.	B IVDR	Fiche EUDAMED Signaler une erreur
HCV antigen	W0105020301	ADVIA Centaur® HCV IVDR_67_TTN_DUB-C_D_KIT_aHCV2 réf.	D IVDR	Fiche EUDAMED Signaler une erreur
Hepatitis b surface antigen - confirmatory	W0105020202	ADVIA Centaur HBsAg Confirmatory (Conf) IVDR_67_TTN_DUB-C_D_REAG_HBsAg Confirmatory2 réf.	D IVDR	Fiche EUDAMED Signaler une erreur
HIV multiple ag/ab combi test	W0105030404	ADVIA Centaur CHIV IVDR_67_TTN_DUB-C_D_KIT_HIV Ag/Ab Combo2 réf.	D IVDR	Fiche EUDAMED Signaler une erreur
Hsv 1 igg	W0105040306	ADVIA Centaur Herpes-1 IgG (HSV1) IVDR_67_TTN_DUB-C_C_KIT_HSV12 réf.	C IVDR	Fiche EUDAMED Signaler une erreur
Hsv 2 igg	W0105040309	ADVIA Centaur Herpes-2 IgG (HSV2) IVDR_67_TTN_DUB-C_C_KIT_HSV22 réf.	C IVDR	Fiche EUDAMED Signaler une erreur
Mixed panel multiparameter analysers - moderate routine (throughput > 800 and <= 2000 test/h)	W0201030102	Atellica CI Analyzer IVDR_67_TTN_DUB-C_A_INST_Atellica CI 1900 Analyzer	A IVDR	Fiche EUDAMED Signaler une erreur
Reagents for (automated) haematology analyzer - other	W0103010199	ADVIA 120/2120/2120i CSF Reagent IVDR_67_TTN_DUB-C_B_REAG_CSF Reagent	B IVDR	Fiche EUDAMED Signaler une erreur
Retrovirus controls - inf.imm.	W0105080803	ADVIA Centaur HIV Ag/Ab Combo Quality Control (CHIV QC) IVDR_67_TTN_DUB-C_D_REAG_ HIV Ag/Ab Combo QC2 réf.	D IVDR	Fiche EUDAMED Signaler une erreur
Rubella virus igg	W0105040102	ADVIA Centaur Rubella G assay IVDR_67_TTN_DUB-C_C_REAG_Rub G assay2 réf.	C IVDR	Fiche EUDAMED Signaler une erreur
Rubella virus igm	W0105040103	ADVIA Centaur Rubella M IVDR_67_TTN_DUB-C_C_REAG_KIT_Rubella M2 réf.	C IVDR	Fiche EUDAMED Signaler une erreur
Samples analyses, plastic cuvettes	W0503010203	Atellica UAS 800 Cuvettes IVDR_69_TTN_DUB-C_A_Centralized Urin- Atellica	A IVDR	Fiche EUDAMED Signaler une erreur
Semi-automated urine analysers	W020101020102	DCA Vantage Analyzer (Professional Use) IVDR_69_TTN_DUB-C_A_NPT_INST_DCA-ACR2 réf.	A IVDR	Fiche EUDAMED Signaler une erreur
Specific reticulocyte reagents	W0103010102	ADVIA 120/2120/2120i® AUTOretic IVDR_67_TTN_DUB-C_A_REAG_autoRETIC2 réf.	A IVDR	Fiche EUDAMED Signaler une erreur
Syphilis antibody assays total	W0105010302	Atellica IM Syphilis (Syph) DX LS_LEGACY_0063041459988598/79	– 98/79	Fiche EUDAMED Signaler une erreur
Syphilis antigen detection	W0105010301	ADVIA Centaur Syphilis DX LS_LEGACY_0063041458017398/79	– 98/79	Fiche EUDAMED Signaler une erreur
Toxoplasma antibody igg	W0105050102	ADVIA Centaur Toxoplasma G IVDR_67_TTN_DUB-C_C_KIT_Toxo G2 réf.	C IVDR	Fiche EUDAMED Signaler une erreur
Toxoplasma antibody igm	W0105050103	ADVIA Centaur Toxoplasma M IVDR_67_TTN_DUB-C_C_KIT_Toxo M2 réf.	C IVDR	Fiche EUDAMED Signaler une erreur
Urinary sediment devices	W0201010202	Atellica UAS 800 Analyzer IVDR_69_TTN_DUB-C_B_INST_Centralized Urin- Atellica	B IVDR	Fiche EUDAMED Signaler une erreur

Un modèle enregistré dans EUDAMED n'est pas forcément commercialisé dans votre pays. Vérifiez la disponibilité et le marquage CE auprès du fabricant.

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