CHEMISTRY ANALYSERS - LOW ROUTINE (Random access without ISE mode test/h <= 400)

EMDN W0201010101

Parent W02010101 CHEMISTRY ANALYSERS

Registry term list. Not a clinical opinion. 342 devices carry this code.

Devices

Name	UDI-DI	Manufacturer	Class	Badge
DxC 500 AU Module, DxC 500i	15099590818234	Beckman Coulter Inc.	Class A	No Certificate Found Snapshot 2026-10-13 · Link to EUDAMED
Electrolyte Analyzer	06975200380938	Shenzhen Xilaiheng Medical Electronics Co.,Ltd.	Class A	No Certificate Found Snapshot 2026-10-13 · Link to EUDAMED
ENVOY 500	08033622963257	Biotecnica Instruments S.r.l.	Class A	No Certificate Found Snapshot 2026-10-13 · Link to EUDAMED
ENVOY 500+	08033622964544	Biotecnica Instruments S.r.l.	Class A	No Certificate Found Snapshot 2026-10-13 · Link to EUDAMED
FastPack IP Analyzer	00816467020396	Qualigen, Inc.	Class A	No Certificate Found Snapshot 2026-10-13 · Link to EUDAMED
FC20 Plus	08058894300036	FUTURLAB S.R.L.	Class A	No Certificate Found Snapshot 2026-10-13 · Link to EUDAMED
Fluorescence immunoassay analyzer	06975239780006	Nano Diagnosis for Health Biotech (Guangzhou) Co., Ltd	Class A	No Certificate Found Snapshot 2026-10-13 · Link to EUDAMED
Fully Auto Glycated Hemoglobin Analyzer	06975200381553	Shenzhen Xilaiheng Medical Electronics Co.,Ltd.	Class A	No Certificate Found Snapshot 2026-10-13 · Link to EUDAMED
FW200	80536089445990	Edif Instruments S.r.l.	Class A	No Certificate Found Snapshot 2026-10-13 · Link to EUDAMED
GBA-1000	06971225930325	Goldsite Diagnostics Inc.	Class A	No Certificate Found Snapshot 2026-10-13 · Link to EUDAMED
HumaLyzer 4000	04033145192305	Human Gesellschaft für Biochemica und Diagnostica mbH	Class A	No Certificate Found Snapshot 2026-10-13 · Link to EUDAMED
HumaLyzer Primus	04033145118664	Human Gesellschaft für Biochemica und Diagnostica mbH	Class A	No Certificate Found Snapshot 2026-10-13 · Link to EUDAMED
HumaStar 100	04033145170198	Human Gesellschaft für Biochemica und Diagnostica mbH	Class A	No Certificate Found Snapshot 2026-10-13 · Link to EUDAMED
HumaStar 200	04033145168140	Human Gesellschaft für Biochemica und Diagnostica mbH	Class A	No Certificate Found Snapshot 2026-10-13 · Link to EUDAMED
HumaStar 300SR	04033145086802	Human Gesellschaft für Biochemica und Diagnostica mbH	Class A	No Certificate Found Snapshot 2026-10-13 · Link to EUDAMED
ILab Aries w/o ISE	08426950490999	Instrumentation Laboratory SpA	Class A	No Certificate Found Snapshot 2026-10-13 · Link to EUDAMED
IMMTOX 270	04580262049901	Biolis Medical Corp.	Class A	No Certificate Found Snapshot 2026-10-13 · Link to EUDAMED
INDIKO	06438153001119	Thermo Fisher Scientific Oy	Class A	No Certificate Found Snapshot 2026-10-13 · Link to EUDAMED
INDIKO PLUS	06438153001133	Thermo Fisher Scientific Oy	Class A	No Certificate Found Snapshot 2026-10-13 · Link to EUDAMED
Indiko Ultra	06438153840503	Thermo Fisher Scientific Oy	Class A	No Certificate Found Snapshot 2026-10-13 · Link to EUDAMED
Indiko Ultra XL	06438153840565	Thermo Fisher Scientific Oy	Class A	No Certificate Found Snapshot 2026-10-13 · Link to EUDAMED
KENZA 240TX - AUTOMATIC BIOCHEMISTRY ANALYSER, including accessories	03760173087181	BIOLABO	Class A	No Certificate Found Snapshot 2026-10-13 · Link to EUDAMED
KENZA MAX BioChemisTry PHOTOMETER	03760173087006	BIOLABO	Class A	No Certificate Found Snapshot 2026-10-13 · Link to EUDAMED
KENZA MAX PLUS BioChemisTry PHOTOMETER	08033675433493	B.P.C. BIOSED – S.R.L.	Class A	No Certificate Found Snapshot 2026-10-13 · Link to EUDAMED
KENZA ONE - AUTOMATIC BIOCHEMISTRY ANALYSER, including accessories	03760173087372	BIOLABO	Class A	No Certificate Found Snapshot 2026-10-13 · Link to EUDAMED
KROMA Automatic Clinical Chemistry Analyzer	08435287393002	Linear Chemicals S.L.U	Class A	No Certificate Found Snapshot 2026-10-13 · Link to EUDAMED
KROMA Plus Automatic Clinical Chemistry Analyzer	08435287393200	Linear Chemicals S.L.U	Class A	No Certificate Found Snapshot 2026-10-13 · Link to EUDAMED
Landwind	06974890940194	Shenzhen Landwind Biomedical Technology Co.,Ltd.	Class A	No Certificate Found Snapshot 2026-10-13 · Link to EUDAMED
Landwind	06974890940200	Shenzhen Landwind Biomedical Technology Co.,Ltd.	Class A	No Certificate Found Snapshot 2026-10-13 · Link to EUDAMED
Landwind	06974890940217	Shenzhen Landwind Biomedical Technology Co.,Ltd.	Class A	No Certificate Found Snapshot 2026-10-13 · Link to EUDAMED
Landwind	06974890940224	Shenzhen Landwind Biomedical Technology Co.,Ltd.	Class A	No Certificate Found Snapshot 2026-10-13 · Link to EUDAMED
Landwind	06974890940231	Shenzhen Landwind Biomedical Technology Co.,Ltd.	Class A	No Certificate Found Snapshot 2026-10-13 · Link to EUDAMED
Landwind	06974890940248	Shenzhen Landwind Biomedical Technology Co.,Ltd.	Class A	No Certificate Found Snapshot 2026-10-13 · Link to EUDAMED
LINX EVO	04719878650311	Skyla Corporation Hsinchu Science Park Branch	Class A	No Certificate Found Snapshot 2026-10-13 · Link to EUDAMED
LordsMed Fully Auto Biochemistry Analyzer (200 TPH)	08906194470037	Lord's Mark Industries Private Limited	Class A	No Certificate Found Snapshot 2026-10-13 · Link to EUDAMED
LordsMed Semi Auto biochemistry Analyzer	08906194470020	Lord's Mark Industries Private Limited	Class A	No Certificate Found Snapshot 2026-10-13 · Link to EUDAMED
Medisys 270	04580262049871	Biolis Medical Corp.	Class A	No Certificate Found Snapshot 2026-10-13 · Link to EUDAMED
MerilyzerAutoQuant 200 i	08905459004550	Meril Diagnostics Pvt. Ltd.	Class A	No Certificate Found Snapshot 2026-10-13 · Link to EUDAMED
MerilyzerAutoQuant 200 i	18906074562187	Meril Diagnostics Pvt. Ltd.	Class A	No Certificate Found Snapshot 2026-10-13 · Link to EUDAMED
MerilyzerAutoQuant 200 i	18906074562415	Meril Diagnostics Pvt. Ltd.	Class A	No Certificate Found Snapshot 2026-10-13 · Link to EUDAMED
MerilyzerAutoQuant 400i	08905459006882	Meril Diagnostics Pvt. Ltd.	Class A	No Certificate Found Snapshot 2026-10-13 · Link to EUDAMED
MerilyzerCliniQuant	18906074561951	Meril Diagnostics Pvt. Ltd.	Class A	No Certificate Found Snapshot 2026-10-13 · Link to EUDAMED
Merilyzer CliniQuant Micro	18906074562194	Meril Diagnostics Pvt. Ltd.	Class A	No Certificate Found Snapshot 2026-10-13 · Link to EUDAMED
Microfluidic clinical chemistry analyzer	06978189070050	Yantai JIEZI Biotechnology Co., Ltd.	Class A	No Certificate Found Snapshot 2026-10-13 · Link to EUDAMED
MR	04897146460104	MR INTERNATIONAL HEALTHCARE TECHNOLOGY CO., LTD.	Class A	No Certificate Found Snapshot 2026-10-13 · Link to EUDAMED
MR	04897146460111	MR INTERNATIONAL HEALTHCARE TECHNOLOGY CO., LTD.	Class A	No Certificate Found Snapshot 2026-10-13 · Link to EUDAMED
MR	04897146460128	MR INTERNATIONAL HEALTHCARE TECHNOLOGY CO., LTD.	Class A	No Certificate Found Snapshot 2026-10-13 · Link to EUDAMED
MR	04897146460135	MR INTERNATIONAL HEALTHCARE TECHNOLOGY CO., LTD.	Class A	No Certificate Found Snapshot 2026-10-13 · Link to EUDAMED
MR	04897146460142	MR INTERNATIONAL HEALTHCARE TECHNOLOGY CO., LTD.	Class A	No Certificate Found Snapshot 2026-10-13 · Link to EUDAMED
MR	04897146460159	MR INTERNATIONAL HEALTHCARE TECHNOLOGY CO., LTD.	Class A	No Certificate Found Snapshot 2026-10-13 · Link to EUDAMED