Singapore HSA registration DE0507722

Terumo K-Pack® II Needle

Singapore·CLASS B·TERUMO EUROPE N.V.·Registered January 31, 2023

Device classification

Device Class: CLASS B
Medical Speciality Area: General Hospital

Registration information

Registration Number: DE0507722
Registration Date: January 31, 2023
Change Notification Approval Date: September 30, 2024
Retention Due Date: January 30, 2026

Product description

The K-Pack® II needle is a sterile hypodermic needle for single use, intended to inject fluids into, or withdraw fluids from, parts of the body below the surface of the skin.

Product Owner

Name: TERUMO EUROPE N.V.
Short Name: TERUMO EUROPE N.V.
Address: Interleuvenlaan 40, 3001 Leuven, BELGIUM

Registrant

Name: TERUMO ASIA HOLDINGS PTE LTD
Address: 300 BEACH ROAD, THE CONCOURSE, #37-01, SINGAPORE 199555

Importer

Name: TERUMO ASIA HOLDINGS PTE LTD TERUMO SINGAPORE PTE LTD
Address: 300 BEACH ROAD, CONCOURSE, THE, #37-01, SINGAPORE 199555 300 BEACH ROAD, CONCOURSE, THE, #33-06, SINGAPORE 199555

Model information

Model Name(s): K-Pack II Needle K-Pack II Needle K-Pack II Needle K-Pack II Needle K-Pack II Needle K-Pack II Needle K-Pack II Needle K-Pack II Needle K-Pack II Needle K-Pack II Needle K-Pack II Needle K-Pack II Needle K-Pack II Needle K-Pack II Needle K-Pack II Needle K-Pack II Needle K-Pack II Needle K-Pack II Needle K-Pack II Needle K-Pack II Needle K-Pack II Needle K-Pack II Needle K-Pack II Needle K-Pack II Needle K-Pack II Needle K-Pack II Needle K-Pack II Needle K-Pack II Needle K-Pack II Needle K-Pack II Needle K-Pack II Needle K-Pack II Needle K-Pack II Needle K-Pack II Needle K-Pack II Needle K-Pack II Needle K-Pack II Needle K-Pack II Needle K-Pack II Needle K-Pack II Needle K-Pack II Needle K-Pack II Needle
Model Identifier(s): KN-1838SB KN-1838SBS KN-1938RB KN-2038RB KN-2038RB500P KN-2138RB KN-2138RB04 KN-2150RB KN-2232RB KN-2232RBB KN-2238RB KN-2325RB KN-2325RB04 KN-2332RB KN-2516RB04 KN-2516RB05 KN-2525RB KN-2525RB04 KN-2610RB KN-2616RB KN-2713RB KN-2713RB500P KN-2713RBK KN-2713RBKT KN-2713RBKTE KN-2713RBKTU KN-2713RBR KN-2713RKT50 KN-2719RB KN-2719RB500P KN-2719RBT KN-2719RBT500P KN-2719RBTS KN-2908RBKT KN-2913RB KN-2913RBKT KN-2913RBS KN-3013RB KN-3013RBKE KN-3013RBKT KN-3013RBKU KN-3013RKT50

About this record

Access comprehensive regulatory information for Terumo K-Pack® II 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 DE0507722 and owned by TERUMO EUROPE N.V.. The device was registered on January 31, 2023.

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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