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Sysmex Automated Hematology Analyzer XN series - HSA Registration DE0010385

Access comprehensive regulatory information for Sysmex Automated Hematology Analyzer XN series in the Singapore medical device market through Pure Global AI's free database. This CLASS B IVD medical device is registered under HSA registration number DE0010385 and owned by Sysmex Corporation. The device was registered on September 07, 2012.

This page provides complete registration details including product owner information, registrant details, importer information, and regulatory compliance data from the official Singapore HSA medical device database. Pure Global AI offers free access to Singapore's complete medical device registry, helping global MedTech companies navigate HSA regulations efficiently.

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CLASS B IVD
DE0010385
Sysmex Automated Hematology Analyzer XN series
HSA Registration Number: DE0010385
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Product Description

The XN series is an automated hematology analyzer for in vitro diagnostic use in clinical laboratories. Only human blood, human body fluids, blood packs or control blood should be run. Any other use is regarded as non-specified.

Device Classification
Device Class
CLASS B IVD
Medical Speciality Area
Hematology
Registration Information
Registration Number
DE0010385
Registration Date
September 07, 2012
Change Notification Approval Date
April 10, 2025
Retention Due Date
September 06, 2025
Product Owner
Short Name
Sysmex
Address
1-5-1 Wakinohama-Kaigandori,, Chuo-ku, Kobe 651-0073, JAPAN
Registrant
Address
9 TAMPINES GRANDE, #06-18, SINGAPORE 528735
Importer
Address
9 TAMPINES GRANDE, #06-18, SINGAPORE 528735
Model Information
Model Name(s)
Pneumatic Unit (PU-17) MICRO SLIDES (MS-101W) MICRO SLIDES (MS-101Y) MICRO SLIDES (MS-101P) WASTE SENSOR COMPLETE SP1K BR (TOUCH65-PRO) SET (FOR SP-1000i) SLIDE CASSETTE STAND ASSAY (PM) WRP CHECK EX CAB 320-DIN 8 TOUCH 65-PRO BR DESK HOLDER SPC-TOUCH 65/90 XN CHECK TM L2 XN CHECK TM L3 XN CHECK TM L1 XN CHECKTM BF XN CALTM PF XN CALTM XN CHECKTM BF SULFOLYSER, SLS-210A Fluorocell WDF, WDF-810A RU-20 CONNECTOR COMPLETE KIT NO.157 (SP-10 RIU) DI Advanced RBC Application XN CAL XN-9000 SUPPLY PARTS WG-85 Automated Hematology Analyzer XN series (XN-20) DI Body Fluid Application WG-20/31 SUPPLY PARTS OUTPUT I/F_ASSY NO.3 COMPLETE SA-31 COMPLETE CF-70 COMPLETE SP-50 SPEED-UP KIT CELLPACK DST, DST-300A WG-10 COMPLETE XN CHECK L2 XN-1000 SUPPLY PARTS XN-3100 SUPPLY PARTS(AP) XN-9100(2) SUPPLY PARTS(AP) CV-65 COMPLETE TB-85(EXP) COMPLETE Lysercell WNR, WNR-200A Automated Hematology Analyzer XN series Transportation Units (TU-40) BT-50 Complete SP-50 SUPPLY PARTS(AP) Automated Hematology Analyzer XN series (XN-10) Automated Hematology Analyzer XN series Transportation Units (CV-50) XN sampler unit (SA-20) CELLPACK DFL, DFL-310A KIT NO.155 (SP-10) CF-70 SUPPLY PARTS (AP) Lyercell CONNECTOR B COMPLETE TA-01 Automated Tube Archiver TS-01 Automated Tube Sorter SA-02 COMPLETE PU-17 CONNECTOR COMPLETE Lysercell WDF, WDF-200A WG-86 Automated Hematology Analyzer XN series Transportation Units (ST-41) CF-70 DOCKING BASE SUPPLY PARTS(XN-1500) CF-70 DOCKING BASE SUPPLY PARTS(XN-9100) DI Remote Review Software RR-10 WG-70 COMPLETE WG-15 COMPLETE Concentrated phosphate buffer for SP pH6.8 WG-84 Lysercell WDF, WDF-220A SA-10 SUPPLY PARTS SULFOLYSER, SLS-240A WG-17 SUPPLY PARTS Automated Hematology Analyzer XN series Transportation Units (WG-50) Automated Hematology Analyzer XN series Transportation Units (WG-60) XN-9100(1) SUPPLY PARTS(AP) CELLPACK DST, DST-320A XN-2000 SUPPLY PARTS XN-9000 PANEL SUPPLY PARTS Fluorocell RET, RET-800A CF-70 DOCKING BASE SUPPLY PARTS (S/A) CF-60 WG-20 COMPLETE SA-30 SUPPLY PARTS Automated Hematology Analyzer XN series Transportation Units (WG-40) SA-21 COMPLETE CELLPACK DST, DST-310A AUTOMATED HEMATOLOGY SLIDE PREARATION UNIT SP-10 XN CHECK L3 CF-60 supply parts RU-20 SUPPLY PARTS Automated Hematology Analyzer XN series Transportation Units (BT-40) CELLPACK DFL, DFL-300A Fluorocell WPC, WPC-800A XN CHECK L1 SP-10 SUPPLY PARTS WG-17 COMPLETE WG-55 Automated Hematology Slide Preparation Unit SP-50 XN CHECK BF Concentrated phosphate buffer for SP pH7.2 WG-80 COMPLETEย  WG-55 SUPPLY PARTS WG-31 COMPLETE Automated Digital Cell Morphology Analyzer DI-60 Automated Hematology Analyzer XN series Transportation Units (CV-70) Automated Hematology Analyzer XN series Transportation Units (WG-30) RANGE CHECK X III Fluorocell PLT, PLT-800A Automated Hematology Analyzer XN series Transportation Units (CV-60) XN-1500 SUPPLY PARTS(AP) CELLCLEAN AUTO Lyercell CONNECTOR A COMPLETE SP-10 CONNECTOR COMPLETE CELLPACK CONNECTOR COMPLETE XN-3000 SUPPLY PARTS (AP) SA-20 SUPPLY PARTS Automated Hematology Analyzer XN series Transportation Units (ST-40) Concentrated phosphate buffer for SP pH7.0 CF-70 DOCKING BASE SUPPLY PARTS(XN-3100) XN sampler unit SA-20/ SA-20 SUPPLY PARTS WG-65 SUPPLY PARTS Automated Hematology Analyzer XN series Transportation Units (SA-30) Platelet Check L1 Fluorocell WNR, WNR-800A XN sampler unit SA-10/ SA-10 SUPPLY PARTS DA-10 COMPLETE DI-60 supply parts XN sampler unit (SA-10) XN-9000 Power Code SUPPLY PARTS Lysercell WPC, WPC-200A RFX connection SUPPLY PARTS WG-65 COMPLETE CELLPACK DCL, DCL-300A RR-20 COMPLETE CELLPACK DCL, DCL-310A Automated Hematology Analyzer XN series Transportation Units CV-55 Spacer No.813 Fluorocell WDF, WDF-800A Automated Hematology Analyzer XN series Transportation Units (ST-42) RB-10 COMPLETE XN CAL PF Concentrated phosphate buffer for SP pH6.6 Reagent Unit (RU-20) Lyse Branch Tube-R WG Complete SULFOLYSER, SLS-210A SULFOLYSER, SLS-220A Immersion Oil Pack, 2x150ml Immersion Oil Pack, 1x150ml Lysercell WDF, WDF-210A CELLPACK DFL Lysercell WDF Lysercell WNR, WNR-210A CELLPACK DCL, DCL-300A CELLPACK DCL, DCL-310A
Model Identifier(s)
01330061 02403118 02403215 02403312 04324718 05308322 05310017 230303 26591515 28195761 28195775 720017816 720017819 720017821 720017822 720017825 720017832 720027707 90411317 AA325279 AA986885 AB709523 AB859211 AE344243 AE415692 AE610525 AE797961 AG241722 AG400759 AG451567 AH258209 AH699752 AH769941 AJ370801 AJ597361 AK060533 AK396054 AM116305 AM368639 AN203513 AN322407 AN577063 AN617358 AN735871 AP414527 AP795756 AQ200900 AR098169 AR829995 AS418339 AS851267 AT250737 AT903180 AU291973 AU879754 AV488271 AW993605 AX241219 AX575334 BA029942 BB993932 BC188562 BC479026 BD557950 BD655831 BF715524 BG131657 BG689680 BH902158 BJ350971 BJ448300 BM168122 BM325917 BM588018 BM808974 BM882285 BM960318 BN337547 BN633651 BN868986 BP050847 BP445069 BP589092 BP758948 BQ505775 BR362571 BR875289 BS155869 BS185331 BT080317 BT965910 BU306227 BV661822 BW831319 BX225885 BX514680 BX765805 BY698063 BZ602091 CA011777 CA759524 CB427017 CC286297 CC652805 CC919708 CC967221 CD994563 CE944580 CF030156 CF579595 CF605061 CG425978 CG595206 CH888821 CH989380 CJ256159 CJ594966 CL237516 CM186605 CN139353 CN292173 CN464998 CP066715 CP366273 CP544945 CR677453 CR690716 CS059858 CS412800 CT003563 CT100587 CT661628 CT932479 CU228496 CU287365 CV022305 CV377552 CV979713 CX205578 CY301935 CY628453 CY662767 CY979584 P90411317 P90411414 XU-10135-01 XU-10135-02 ZPPAL337564 ZPPAR829995 ZPPAV021787 ZPPBL121531 ZPPCT661628 ZPPCU228496