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Singapore HSA registration DE0510142

Sandstone Medical Easydrip ReadyGard Duo Safety Pen Needles

Singapore flagSingapore·CLASS B·Sandstone Medical (Suzhou) Inc.·Registered December 13, 2024
Device classification
Device Class
CLASS B
Medical Speciality Area
General Hospital
Registration information
Registration Number
DE0510142
Registration Date
December 13, 2024
Retention Due Date
December 12, 2025
Product description
The safety pen needle is intended for use with pen injector devices for subcutaneous injection of drugs. Additionally, the product has two safety shields, which lock in place after use (patient end) and upon removal of the needle from the pen (pen connection end). The locked shields help reduce the occurrence of needle sticks from both ends of the needle.
Product Owner
Name
Sandstone Medical (Suzhou) Inc.
Short Name
Sandstone Medical (Suzhou) Inc.
Address
Building 6, No. 168 PuTuoShan Road, New District, 215153 Suzhou, Jiangsu Province, CHINA
Registrant
Name
BIOMED DIAGNOSTICS PTE LTD
Address
18 BOON LAY WAY, TRADEHUB 21, #05-105, SINGAPORE 609966
Importer
Name
BIOMED DIAGNOSTICS PTE LTD
Address
18 BOON LAY WAY, TRADEHUB 21, #05-105, SINGAPORE 609966
Model information
Model Name(s)
Easydrip ReadyGard Duo Easydrip ReadyGard Duo Easydrip ReadyGard Duo
Model Identifier(s)
403715 404811 440239
About this record

Access comprehensive regulatory information for Sandstone Medical Easydrip ReadyGard Duo Safety Pen Needles in the Singapore medical device market through Pure Global AI's free database. This CLASS B medical device is registered under HSA registration number DE0510142 and owned by Sandstone Medical (Suzhou) Inc.. The device was registered on December 13, 2024.

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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