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PT. NIPRO INDONESIA JAYA AV FISTULA NEEDLE - HSA Registration DE0016084

Access comprehensive regulatory information for PT. NIPRO INDONESIA JAYA AV FISTULA NEEDLE in the Singapore medical device market through Pure Global AI's free database. This CLASS B medical device is registered under HSA registration number DE0016084 and owned by PT. NIPRO INDONESIA JAYA. The device was registered on August 04, 2014.

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
DE0016084
PT. NIPRO INDONESIA JAYA AV FISTULA NEEDLE
HSA Registration Number: DE0016084
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Product Description

AV Fistula needles are indicated for hemodialysis, hemofiltration and hemodiafiltration. This products are indicated for use in conjunction with other procedures requiring access to the blood stream.

Device Classification
Device Class
CLASS B
Medical Speciality Area
Gastroenterology & Urology
HSA Product Code
HSAMDB00110
HS Code
90183990
Registration Information
Registration Number
DE0016084
Registration Date
August 04, 2014
Change Notification Approval Date
January 13, 2025
Retention Due Date
August 03, 2025
Product Owner
Short Name
PT. NIPRO INDONESIA JAYA
Address
JL. Surya Utama Kav. I-22B, 23 & 24, Kawasan Industri Suryacipta, - Kutamekar Ciampel - Karawang -, Jawa barat 41361 -Indonesia, INDONESIA REP OF
Registrant
Address
6 TEMASEK BOULEVARD, SUNTEC TOWER FOUR, #31-01/02, SINGAPORE 038986
Importer
Address
6 TEMASEK BOULEVARD, SUNTEC TOWER FOUR, #31-01/02, SINGAPORE 038986 10 JOO KOON CRESCENT, SINGAPORE 629012
Model Information
Model Name(s)
Nipro AV Fistula Needle 14G Nipro AV Fistula Needle 14G Nipro AV Fistula Needle 14G Nipro AV Fistula Needle 14G Nipro AV Fistula Needle 14G Nipro AV Fistula Needle 14G Nipro AV Fistula Needle 15G Nipro AV Fistula Needle 15G Nipro AV Fistula Needle 15G Nipro AV Fistula Needle 15G Nipro AV Fistula Needle 15G Nipro AV Fistula Needle 15G Nipro AV Fistula Needle 16G Nipro AV Fistula Needle 16G Nipro AV Fistula Needle 16G Nipro AV Fistula Needle 16G Nipro AV Fistula Needle 16G Nipro AV Fistula Needle 16G Nipro AV Fistula Needle 17G Nipro AV Fistula Needle 17G Nipro AV Fistula Needle 17G Nipro AV Fistula Needle 17G Nipro AV Fistula Needle 17G Nipro AV Fistula Needle 17G
Model Identifier(s)
14GX1" HC-15 14GX1" HC-30 14GX1-1/4" HC-15 14GX1-1/4" HC-30 14GX4/5" HC-15 14GX4/5" HC-30 15GX1" HC-15 15GX1" HC-30 15GX1-1/4" HC-15 15GX1-1/4" HC-30 15GX4/5" HC-15 15GX4/5" HC-30 16GX1" HC-15 16GX1" HC-30 16GX1-1/4" HC-15 16GX1-1/4" HC-30 16GX4/5" HC-15 16GX4/5" HC-30 17GX1" HC-15 17GX1" HC-30 17GX1-1/4" HC-15 17GX1-1/4" HC-30 17GX4/5" HC-15 17GX4/5" HC-30