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Sysmex Automated Hematology Analyzer XN-L series - HSA Registration DE0010268

Access comprehensive regulatory information for Sysmex Automated Hematology Analyzer XN-L 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 DE0010268 and owned by SYSMEX CORPORATION. The device was registered on September 06, 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
DE0010268
Sysmex Automated Hematology Analyzer XN-L series
HSA Registration Number: DE0010268
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Product Description

The XN-L series are automated hematology analyzers for in vitro diagnostic use in clinical laboratories. Only human blood, human body fluids 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
DE0010268
Registration Date
September 06, 2012
Change Notification Approval Date
April 11, 2025
Retention Due Date
September 05, 2025
Product Owner
Short Name
SYSMEX CORPORATION
Address
4-4-4 Takatsukadai, Nishi-ku, Kobe 651-2271, 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 WASTE CONTAINER SENSOR ASSY NO.1 WRP CHECK EX XN CHECK L2 XN-L CHECK L3 XN-L CHECK L1 XN CHECK L3 XN CHECK L1 XN CHECK BF XN-L CHECK L2 XN CAL XN CHECK BF SULFOLYSER Fluorocell WDF XN CAL CDR_ASSY NO.350 CDR_ASSY NO.329 CDR_ASSY NO.381 CELLPACK DST CDR_ASSY NO.463 XN CHECK L2 CDR_ASSY NO.311 XN-350/450 Supply Parts CDR_ASSY NO.230 CDR_ASSY No.236 CELLPACK DFL XN-L CHECK L3 Lysercell WDF Automated Hematology Analyzer XN-L series XN-350 CDR_ASSY NO.238 Automated Hematology Analyzer XN-L series XN-550 XN-550 Supply Parts CDR_ASSY NO.368 Lysercell WDF SULFOLYSER XN-L CHECK L1 CELLPACK DST Automated Hematology Analyzer XN-L series XN-450 Fluorocell RET CELLPACK DST XN CHECK L3 RU-20 SUPPLY PARTS CELLPACK DFL XN-330 SUPPLY PARTS XN CHECK L1 CDR_ASSY NO.390 XN CHECK BF XN-L CHECK L2 CDR_ASSY NO.297 RANGE CHECK X III CELLCLEAN AUTO CDR_ASSY NO.270 CDR_ASSY NO.416 CDR_ASSY NO.279 CELLPACK DCL CELLPACK DCL Fluorocell RET Fluorocell WDF CDR_ASSY NO.324 Automated Hematology Analyzer XN-L series XN-330 Reagent Unit RU-20 SULFOLYSER Lysercell WDF Lysercell WDF CELLPACK DCL CELLPACK DCL
Model Identifier(s)
01330061 02315354 230303 720017816 720017817 720017818 720017819 720017821 720017822 720017823 720017832 720027707 904-1131-7 AA-325-279 AE-344-243 AE920163 AF257076 AF578345 AJ-370-801 AJ202389 AK-060-533 AK137038 AL951256 AP019210 AP595743 AR-829-995 AS-975-028 AW-993-605 AW618382 AX820355 BD634545 BE398308 BF326676 BG-689-680 BJ-350-971 BL-254-184 BM-808-974 BM392756 BN-337-547 BQ-505-775 BR-875-289 BS185331 BT-965-910 BU896197 BV-661-822 BW224024 BY-698-063 CB-060-015 CC604816 CC967221 CF-579-595 CG426217 CH685650 CS098008 CT-661-628 CU-228-496 CU-920-210 CV-377-552 CX325412 CX851950 CY662767 P90411317 ZPPAL337564 ZPPAV021787 ZPPCT661628 ZPPCU228496