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Sysmex Fully Automated Urine Chemistry Analyzer UC-3500 - HSA Registration DE0018683

Access comprehensive regulatory information for Sysmex Fully Automated Urine Chemistry Analyzer UC-3500 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 DE0018683 and owned by SYSMEX CORPORATION. The device was registered on October 20, 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
DE0018683
Sysmex Fully Automated Urine Chemistry Analyzer UC-3500
HSA Registration Number: DE0018683
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Product Description

Fully Automated Urine Chemistry Analyzer UC-3500 is an in vitro diagnostic instrument for the determination of clinical parameters in human urine. The instrument can only be used to analyze human urine 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
DE0018683
Registration Date
October 20, 2016
Change Notification Approval Date
May 15, 2025
Retention Due Date
October 19, 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)
CELLCLEAN U-RDU SUPPLY PARTS C2 (UC) CDR_ASSY NO.237 CONNECTIONKIT2(UC-CV) GAP SHIELD (UC-LEFT) Urine Sample Transportation Unit CV-11 CONNECTION KIT (UC-CV) UC-CONTROL MEDITAPE UC-9A GAP SHIELD (UC-UF) WG-13 SIDE PANEL KIT Urine Sample Transportation Unit ST-11 CDR_ASSY NO.312 CDR_ASSY NO.251 Fully Automated Urine Chemistry Analyzer UC-3500 Riser for CV-11 KIT NO.463 Urine Sample Transportation Unit ST-10 Urine Sample Transportation Unit ST-12 GAP SHIELD (UC-UC) CDR_ASSY NO.309 CDR_ASSY NO.266 SI-20 KIT NO. 431 CV-11 SUPPLY PARTS GAP SHIELD (UC-RIGHT) Reagent Distribution Unit U-RDU WG-45 KIT No.452  SG Calibrator MEDITAPE UC-11A WG-44 UC-3500 IFU (AP) COMPLETE UC-3500 SUPPLY PARTS CDR_ASSY NO.265
Model Identifier(s)
83401621 AA577350 AC951271 AD456391 AL480643 AN993713 AU441141 AU448468 AX119225 AY681113 BA082647 BA280295 BD559290 BE412639 BF266363 BH756473 BJ322011 BM631245 BQ027353 BU315716 BU489878 BV944251 CD641161 CG288873 CG631695 CH047388 CJ636661 CJ713807 CK161261 CK523920 CK920648 CM374009 CQ079424 CU692631 CY401109 CZ852665