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Singapore HSA registration DE0509429

Mirai Medical ePORE

Singapore flagSingapore·CLASS C·Mirai Medical Ltd·Registered June 21, 2024
Device classification
Device Class
CLASS C
Medical Speciality Area
General & Plastic Surgery
Registration information
Registration Number
DE0509429
Registration Date
June 21, 2024
Retention Due Date
June 20, 2026
Product description
Intended for non-responsive or limited responsive tumours. - Intended to improve uptake of pharmaceutical Bleomycin administrated intravenously and/or intratumorally. - Intended for patient of aged 18 and above. - Indicated for local treatment of cutaneous and subcutaneous tumours (melanoma, squamous cell carcinoma, and Kaposi sarcoma), treatment of local skin tumour relapse and electroporation of metastatic cutaneous and subcutaneous tumours from underlying primary breast cancer.
Product Owner
Name
Mirai Medical Ltd
Short Name
Mirai Medical Ltd
Address
Unit 5 Howley Court, Dublin Rd, Oranmore Galway, H91FK6, IRELAND
Registrant
Name
MEDICAL IMAGING SYSTEMS PTE. LTD.
Address
28 SIN MING LANE, MIDVIEW CITY, #02-143, SINGAPORE 573972
Importer
Name
MEDICAL IMAGING SYSTEMS PTE. LTD.
Address
3006 UBI ROAD 1, KAMPONG UBI INDUSTRIAL ESTATE, #02-336, SINGAPORE 408700
Model information
Model Name(s)
CUTIS ePore Generator Extension Lead CUTIS Low Frequency
Model Identifier(s)
700245 MMHT1 MS-19-04
About this record

Access comprehensive regulatory information for Mirai Medical ePORE in the Singapore medical device market through Pure Global AI's free database. This CLASS C medical device is registered under HSA registration number DE0509429 and owned by Mirai Medical Ltd. The device was registered on June 21, 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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