Singapore HSA registration DE0017197
Kora Regelle Long Lasting Vaginal Moisturiser
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 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.
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
About this record
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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