Manufacturer

Lifotronic

ChinaLegal entities : Shenzhen Lifotronic Technology Co., Ltd.

First countries of placing on the market declared in EUDAMED : France, Germany, Ireland, Italy, Netherlands

EU representative : Shanghai International Holding Corp. GmbH(Europe) (Germany)

41 categories, 139 models including 139 on the market, 1 country

On the market
No longer marketed
93/42 Former directive, not yet certified under the MDR
Click a category to see competitors, a model to open its EUDAMED record.

Category	EMDN code	Registered models	Class	Contact
High performance liquid chromatography systems	W0201050201	1000 mL2 refs 3 × 2L 500 mL2 refs 600 mL3 refs H898/79 5 others Hb NEXT Hemoglobin analyzer(HPLC) Hb NEXT（50 samples,110 samples ）2 refs Hemoglobin Analyzer(HPLC) H6, H8, H9, H100, H100Plus, 96TH, A10TH, A10,3 refs V60 analytical column 1 piece/box98/79 V80 analytical column 1 piece/box98/79 ß-THALASSAEMIA & HbA1c Assay Column (HPLC) H998/79	A IVDR, 98/79	EUDAMED record Report an error
Other haemoglobin (types) testing - other	W0103010299	Eluent A 400 mL, 800 mL, 1600 mL9 refs Eluent B 400 mL, 800 mL6 refs Eluent C 400 mL, 800 mL6 refs Eluent D 400 mL, 800 mL, 1600 mL8 refs Hb NEXT Eluent A 1 × 800 mL 4 others HbA1c Reagent Kits (HPLC) 100T, 200T, 400T3 refs Hemolytic Agent L 2500 mL, 5000 mL2 refs Probe Rinse Solution 30 mL, 50 mL, 5 mL*53 refs THALASSAEMIA & HbA1c Reagent Kit (HPLC) 200T, 400T2 refs	A IVDR	EUDAMED record Report an error
High performance liquid chromatography systems - hardware accessories	W0201050280	Chromatographic Column(HPLC) GH-900Plus98/79 Chromatographic Column(HPLC) GH-900Plus, H8, H9, H100, H100Plus Chromatographic Column(HPLC) H100Plus3 refs98/79 Chromatographic Column(HPLC) H998/79 Hb NEXT analytical column 1 column and 2 filters per box98/79 3 others Hb NEXT analytical column 1 column and 4 filters per box98/79 ß-THALASSAEMIA & HbA1c Assay Column(HPLC) H898/79 ß-THALASSAEMIA & HbA1c Assay Column(HPLC) H8, H9, H1003 refs	C IVDR, 98/79	EUDAMED record Report an error
D-dimer	W0103020503	D-dimer Assay Kit (Lateral Flow Immunoassay) 50 Tests/Kit98/79 D-Dimer STAT (eCLIA) 100T98/79 D-Dimer STAT (eCLIA) 2×100T98/79 D-Dimer STAT (eCLIA) 2×50T98/79 D-Dimer STAT (eCLIA) 50T，2×50T，100T，2×100T2 refs 1 other D-dimer Assay Kits (Lateral Flow Immunoassay)3 refs	C IVDR, 98/79	EUDAMED record Report an error
Interleukin 6 (il-6)	W01030609	IL-6 STAT (eCLIA) 100T98/79 IL-6 STAT (eCLIA) 50T98/79 IL-6 STAT (eCLIA) 50T，2×50T，100T，2×100T2 refs Interleukin-6 (Electrochemiluminescence Immunoassay)3 refs Interleukin-6 (Electrochemiluminescence Immunoassay) 2×100 T98/79 1 other Interleukin-6 (Electrochemiluminescence Immunoassay) 50 T98/79	B IVDR, 98/79	EUDAMED record Report an error
Chagas	W0105050202	Chagas (eCLIA) 100T98/79 Chagas (eCLIA) 200T98/79 Chagas (eCLIA) 2×50T98/79 Chagas (eCLIA) 50T98/79 Chagas Controls Level 1: 3×1.0 mL, Level 2: 3×1.0 mL98/79	– 98/79	EUDAMED record Report an error
Haemoglobin controls	W0103010504	HbA1c Control Material Level 1: 1×0.5mL; Level 2: 1×0.5mL98/79 HbA1c Control Material The kit includes Control Material Level 1 and Level 2 2 × 0.1mL / vials98/79 ß-THALASSAEMIA & HbA1c Control Material ß-THALASSAEMIA & HbA1c Control Material The kit includes Control Material Level 1, Level 2, 2×0.1mL98/79 ß-THALASSAEMIA & HbA1c Control Material The kit includes Control Material Level 1, Level 2. ：2×0.5mL.98/79	C IVDR, 98/79	EUDAMED record Report an error
Reagents for DNA and/or RNA extraction and preparation: bacteria and/or virus	W0105900101	32T/Kit 48T/Kit 64T/Kit 8T/Kit 96T/Kit	A IVDR	EUDAMED record Report an error
Coagulation inhibitors - other	W0103020699	TM (eCLIA) 100T98/79 TM (eCLIA) 2×100T98/79 TM (eCLIA) 2×50T98/79 TM (eCLIA) 50T98/79	– 98/79	EUDAMED record Report an error
Ebv ebna igg	W010504040106	EBV EBNA IgG (eCLIA) 100T98/79 EBV EBNA IgG (eCLIA) 2×100T98/79 EBV EBNA IgG (eCLIA) 2×50T98/79 EBV EBNA IgG (eCLIA) 50T98/79	– 98/79	EUDAMED record Report an error
Ebv igm - total	W010504040103	EBV IgM (eCLIA) 100T98/79 EBV IgM (eCLIA) 2×100T98/79 EBV IgM (eCLIA) 2×50T98/79 EBV IgM (eCLIA) 50T98/79	– 98/79	EUDAMED record Report an error
Ebv vca igg	W010504040105	EBV VCA IgG (eCLIA) 100T98/79 EBV VCA IgG (eCLIA) 2×100T98/79 EBV VCA IgG (eCLIA) 2×50T98/79 EBV VCA IgG (eCLIA) 50T98/79	– 98/79	EUDAMED record Report an error
Fibrinogen degradation products	W0103020502	FDP (eCLIA) 100T98/79 FDP (eCLIA) 2×50T98/79 FDP (eCLIA) 50T98/79 FDP (eCLIA) 50T, 2×50T, 100T, 2×100T	C IVDR, 98/79	EUDAMED record Report an error
Hsv 1 igg	W0105040306	HSV-I IgG (eCLIA) 100T98/79 HSV-I IgG (eCLIA) 2×100T98/79 HSV-I IgG (eCLIA) 2×50T98/79 HSV-I IgG (eCLIA) 50T98/79	– 98/79	EUDAMED record Report an error
Hsv 1 igm	W0105040307	HSV-I IgM (eCLIA) 100T98/79 HSV-I IgM (eCLIA) 2×100T98/79 HSV-I IgM (eCLIA) 2×50T98/79 HSV-I IgM (eCLIA) 50T98/79	– 98/79	EUDAMED record Report an error
Hsv 2 igg	W0105040309	HSV-II IgG (eCLIA) 100T98/79 HSV-II IgG (eCLIA) 2×100T98/79 HSV-II IgG (eCLIA) 2×50T98/79 HSV-II IgG (eCLIA) 50T98/79	– 98/79	EUDAMED record Report an error
Hsv 2 igm	W0105040310	HSV-II IgM (eCLIA) 100T98/79 HSV-II IgM (eCLIA) 2×100T98/79 HSV-II IgM (eCLIA) 2×50T98/79 HSV-II IgM (eCLIA) 50T98/79	– 98/79	EUDAMED record Report an error
Plasmin - a2 - antiplasmin complex	W0103020305	PIC (eCLIA) 100T98/79 PIC (eCLIA) 2×100T98/79 PIC (eCLIA) 2×50T98/79 PIC (eCLIA) 50T98/79	– 98/79	EUDAMED record Report an error
Plasminogen activator-inhibitors	W0103020506	t-PAIC (eCLIA) 100T98/79 t-PAIC (eCLIA) 2×100T98/79 t-PAIC (eCLIA) 2×50T98/79 t-PAIC (eCLIA) 50T98/79	– 98/79	EUDAMED record Report an error
Syphilis antibody assays total	W0105010302	Syphilis (eCLIA) 100T98/79 Syphilis (eCLIA) 2×100T98/79 Syphilis (eCLIA) 2×50T98/79 Syphilis (eCLIA) 50T98/79	– 98/79	EUDAMED record Report an error
Thrombin-antithrombin III-complex	W0103020307	TAT (eCLIA) 100T98/79 TAT (eCLIA) 2×100T98/79 TAT (eCLIA) 2×50T98/79 TAT (eCLIA) 50T98/79	– 98/79	EUDAMED record Report an error
Tumour necrosis factors (tnfα,tnfβ, ...)	W01030603	TNF-alpha (eCLIA) 100T98/79 TNF-alpha (eCLIA) 2×100T98/79 TNF-alpha (eCLIA) 2×50T98/79 TNF-alpha (eCLIA) 50T98/79	– 98/79	EUDAMED record Report an error
Automated immunochemistry analysers - moderate to high routine (throughput > 250 and <= 700 test/h)	W0201020103	Automated ECLImmunoassay Analyzer eCL9000、eCL9600、eCL9900、eCL9900i3 refs VITROS™ ECL 260 Immunodiagnostic System VITROS™ ECL 300 Immunodiagnostic System	A IVDR	EUDAMED record Report an error
Dengue - RT & POC	W0105099007	Dengue IgG/IgM Antibody Test (GICA) 25T98/79 Dengue NS1 Antigen Test (GICA) 25T98/79 Dengue NS1/IgG/IgM Test (GICA) 25T98/79	– 98/79	EUDAMED record Report an error
Whole blood calibrators	W0103010507	HbA1c Calibrator The kit includes calibrator level 1and level 2 2 × 0.1 mL / vials98/79 ß-THALASSAEMIA & HbA1c Calibrator ß-THALASSAEMIA & HbA1c Calibrator The kit includes calibrator level 1, level 2, 2×0.1mL98/79	C IVDR, 98/79	EUDAMED record Report an error
Automated immunochemistry analysers - low routine (throughput <= 100 test/h)	W0201020101	Automated ECL Immunoassay Analyzer eCL8000,eCL8000i,eCL8000p,eCL8000x, Robot_R1 VITROS™ ECL 86 Immunodiagnostic System	A IVDR	EUDAMED record Report an error
General medicine therapeutic treatment instruments - consumables	Z12040285	Garment FV-20，FV-21，FV-22，FV-23，FV-24，FV-25，FV-26，WV-20，WV-21，WV-22，WV-23，WV-24，WV-25，FV-10，FV-11，FV-12，FV-13，FV-14，FV-15，FV-16，WV-10，WV-11，WV-12，WV-13，WV-14，WV-153 refs Sleeve SAP-RH-M，SAP-RF-M，SAP-AM-M，MAP-RH-M，MAP-RF-M，MAP-AM-M，MAP-AC-M，SAP-SH-M，MAP-RR-M，MAP-BE-L，SAP-LH-M，SAP-LF-M，SAP-LG-M，SAP-LG-S，SAP-LG-L，MAP-LH-M，MAP-LF-M，MAP-LG-M，MAP-LC-M，MAP-SH-M，MAP-RL-M，SAP-SH-XL3 refs	I MDR	EUDAMED record Report an error
Haemoglobin determinations (total hb)	W0103010201	HbA1c calibrator 2×0.1mL98/79 HbA1c Control Material 2×0.1mL98/79	– 98/79	EUDAMED record Report an error
Samples analyses, plastic tubes - accessories	W050301020180	Assay Cup 300T,3000T2 refs Assay Cup/Assay Tip 1×6×105、6×6×105、12×2×1053 refs	A IVDR	EUDAMED record Report an error
Automated immunochemistry analysers - moderate routine (throughput > 100 and <= 250 test/h)	W0201020102	Automated ECLImmunoassay Analyzer eCL8600, eCL8600i, eCL8600p, eCL8800, eCL8800i, eCL8800p3 refs	A IVDR	EUDAMED record Report an error
Body thermoregulation equipment	Z12040208	Temperature Management System TC-200,TC-150,TC-1003 refs	IIb MDR	EUDAMED record Report an error
H. pylori - RT & POC	W0105090102	H.Pylori Ag Test (GICA) 25 Tests/Kit98/79	– 98/79	EUDAMED record Report an error
Influenza a and /or b - RT & POC	W0105099004	Influenza A&B Test (GICA) 25T98/79	– 98/79	EUDAMED record Report an error
Limited panel electrophoresis analysers - hardware accessories	W020105010280	Chromatographic Column(HPLC) H10098/79	– 98/79	EUDAMED record Report an error
Nucleic acid testing instruments except micro-arrays - other	W02050199	Automated Nucleic Acid Purification System PureStar-32	A IVDR	EUDAMED record Report an error
Pipettes, tips without filter	W0503020202	VITROS™ ECL Assay Cup/Assay Tip 6×6×105	A IVDR	EUDAMED record Report an error
Plasmodium (malaria) - RT & POC	W0105090401	Malaria P.f/Pan Test (GICA) 25T98/79	– 98/79	EUDAMED record Report an error
Samples analyses, plastic microtubes without additives	W050301020202	VITROS™ ECL Assay Cup 3000 T	A IVDR	EUDAMED record Report an error
Shock wave therapy equipment	Z12139001	LC-560,LC-570,LC-310,LC-320	IIa MDR	EUDAMED record Report an error
Various instruments for general and multidisciplinary surgery - consumables	Z12019085	Canister CS300, CS500, CL500, CL10003 refs	I MDR	EUDAMED record Report an error
Various rapid test chemistry / immunochemistry instruments - other	W0201069099	Lateral Flow Immunoassay Analyzer FA-160	A IVDR	EUDAMED record Report an error

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