Pure Global
Singapore HSA registration DE0504200

Amity Amity OPA Sporicidal High Level Disinfectant

Singapore flagSingapore·CLASS C·Amity International·Registered March 06, 2020
Device classification
Device Class
CLASS C
Medical Speciality Area
General Hospital
Registration information
Registration Number
DE0504200
Registration Date
March 06, 2020
Retention Due Date
March 05, 2026
Product description
Amity OPA is a powerful o-phthalaldehyde based sporicidal high level disinfectant for use in Automated Endoscope Reprocessors (AERs) and manual contamination systems. It is a disinfectant for flexible endoscopes and medical devices and does not require activation prior to use
Product Owner
Name
Amity International
Short Name
Amity
Address
Libra House, Spring Park,, Clayburn Road, Park Springs,, Barnsley, South Yorkshire, S72 7FD, UNITED KINGDOM
Registrant
Name
BIOCARE GLOBAL PTE. LTD.
Address
50 BUKIT BATOK STREET 23, MIDVIEW BUILDING, #06-03, SINGAPORE 659578
Importer
Name
BIOCARE GLOBAL PTE. LTD.
Address
50 BUKIT BATOK STREET 23, MIDVIEW BUILDING, #06-03, SINGAPORE 659578
Model information
Model Name(s)
Amity OPA
Model Identifier(s)
OPA
About this record

Access comprehensive regulatory information for Amity Amity OPA Sporicidal High Level Disinfectant in the Singapore medical device market through Pure Global AI's free database. This CLASS C medical device is registered under HSA registration number DE0504200 and owned by Amity International. The device was registered on March 06, 2020.

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.

Free DatabasePowered by Pure Global AIHSA Official DataCLASS C