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Sysmex Fully Automated Urine Particle Analyzer UF-4000/UF-5000 - HSA Registration DE0018714

Access comprehensive regulatory information for Sysmex Fully Automated Urine Particle Analyzer UF-4000/UF-5000 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 DE0018714 and owned by SYSMEX CORPORATION. The device was registered on November 08, 2016.

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
DE0018714
Sysmex Fully Automated Urine Particle Analyzer UF-4000/UF-5000
HSA Registration Number: DE0018714
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Product Description

In vitro diagnostic instrument for the determination of clinical parameters in human urine and human body fluids. The instrument can only be used to analyze human urine, body fluid, and control material samples. It cannot be used for any other purpose.

Device Classification
Device Class
CLASS B IVD
Medical Speciality Area
Clinical chemistry
Registration Information
Registration Number
DE0018714
Registration Date
November 08, 2016
Change Notification Approval Date
May 15, 2025
Retention Due Date
November 07, 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 CELLCLEAN UF Sampler Unit SA-51 CDR_ASSY NO.232 IPU RACK (UD) UF-Fluorocell CR CDR_ASSY NO.205 CDR_ASSY NO.206 Urine Sample Transportation Unit CV-11 GAP SHIELD (UD-LEFT) COMPLETE UF-4000 SUPPLY PARTS(AP)                     GAP SHIELD (UF-UF) COMPLETE Urinalysis Workarea Information Management System U-WAM CONNECTION KIT (UD-CV) GAP SHIELD (UC-UF) COMPLETE CONNECTION KIT2(UD-CV) COMPLETE WG-13 Fully Automated Urine Particle Analyzer UF-4000 SIDE PANEL KIT Urine Sample Transportation Unit ST-11 CDR_ASSY NO.312 UF-CONTROL CDR_ASSY NO.251 GAP SHIELD (UF-UD) COMPLETE Riser for CV-11 KIT NO.463 UF-5000 SUPPLY PARTS(AP) Fully Automated Urine Particle Analyzer UF-5000 Urine Sample Transportation Unit ST-10 CDR_ASSY NO.229 Urine Sample Transportation Unit ST-12 CDR_ASSY NO.309 UF-CELLSHEATH CONNECTION KIT (UF-CV) UF-CELLPACK CR CDR_ASSY NO.266 UF-CELLPACK SF UF-Fluorocell SF SI-20 KIT NO. 431 CV-11 SUPPLY PARTS Fully Automated Urine Particle Digital Imaging Device UD-10 Reagent Distribution Unit U-RDU UD-10 SUPPLY PARTS WG-45 GAP SHIELD (UF-RIGHT) COMPLETE UF-CALIBRATOR WG-44 KIT NO. 451 GAP SHIELD (UF-LEFT) COMPLETE U-RDU SUPPLY PARTS CONNECTION KIT2(UF-CV) COMPLETE CDR_ASSY NO.265 UF-CELLSHEATH UF-CELLPACK CR UF-CELLPACK SF
Model Identifier(s)
01330061 83401621 AA297665 AC006811 AG049644 AG792864 AH061829 AJ475442 AN993713 AP695651 AR378163 AU250961 AU501736 AW078479 AY681113 AZ959872 BA082647 BA212287 BA280295 BD559290 BE412639 BE740265 BF266363 BH787282 BJ322011 BM631245 BM752310 BN344411 BQ027353 BR894492 BU315716 BV944251 BY074501 CB486352 CB505392 CD641161 CE604532 CE919553 CG288873 CG631695 CH047388 CJ445012 CJ713807 CJ807916 CK161261 CK598082 CN383000 CQ079424 CQ781769 CY444368 CZ205099 CZ580769 CZ852665 ZPPBY074501 ZPPCB505392 ZPPCE604532