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Kora Regelle Long Lasting Vaginal Moisturiser - HSA Registration DE0017197

Access comprehensive regulatory information for Kora Regelle Long Lasting Vaginal Moisturiser in the Singapore medical device market through Pure Global AI's free database. This CLASS B medical device is registered under HSA registration number DE0017197 and owned by KORA CORPORATION LTD. The device was registered on May 25, 2015.

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
DE0017197
Kora Regelle Long Lasting Vaginal Moisturiser
HSA Registration Number: DE0017197
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Product Description

Regelle is a NON-hormone based intra-vaginal gel which can be used in conjunction with hormone replacement therapy. Regelle helps provide relief from symptoms of vaginal atrophy and dryness, itching, irritation and discomfort.

Device Classification
Device Class
CLASS B
Medical Speciality Area
General Hospital
HSA Product Code
HSAMDB00110
HS Code
30067000
Registration Information
Registration Number
DE0017197
Registration Date
May 25, 2015
Retention Due Date
May 24, 2025
Product Owner
Short Name
KORA CORPORATION LTD
Address
SWORDS BUSINESS PARK, SWORDS, CO, DUBLIN, DUBLIN, IRELAND
Registrant
Address
1 KAKI BUKIT ROAD 1, ENTERPRISE ONE, #02-44, SINGAPORE 415934
Importer
Address
160 PAYA LEBAR ROAD, ORION @ PAYA LEBAR, #05-03, SINGAPORE 409022
Model Information
Model Name(s)
Regelle Long Lasting Vaginal Moisturiser
Model Identifier(s)
3 Single Use Pre-Filled Applicators