Singapore HSA registration DE0503129
Coloplast DORMIA® No-Tip and N.stone extractor
Device classification
- Device Class
- CLASS B
- Medical Speciality Area
- General Hospital
Registration information
- Registration Number
- DE0503129
- Registration Date
- May 20, 2019
- Change Notification Approval Date
- August 29, 2024
- Retention Due Date
- May 19, 2026
Product description
Extraction of urinary tract calculi.
Product Owner
- Name
- Coloplast A/S
- Short Name
- Coloplast A/S
- Address
- Holtedam 1, 3050 Humlebaek, DENMARK
Registrant
- Address
- 10 ANSON ROAD, INTERNATIONAL PLAZA, #15-18, SINGAPORE 079903
Importer
- Address
- 40 JALAN PEMIMPIN, TAT ANN BUILDING, #03-01C, SINGAPORE 577185
Model information
- Model Name(s)
- DORMIA® NO TIP STONE EXTRACTOR DORMIA® NO TIP STONE EXTRACTOR DORMIA® NO TIP STONE EXTRACTOR DORMIA® N-STONE STONE EXTRACTOR DORMIA® N-STONE STONE EXTRACTOR DORMIA® N-STONE STONE EXTRACTOR
- Model Identifier(s)
- EXN434 EXN734 EXN934 EXT224 EXT424 EXT624
About this record
Access comprehensive regulatory information for Coloplast DORMIA® No-Tip and N.stone extractor in the Singapore medical device market through Pure Global AI's free database. This CLASS B medical device is registered under HSA registration number DE0503129 and owned by Coloplast A/S. The device was registered on May 20, 2019.
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 B