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Coloplast DORMIA® No-Tip and N.stone extractor - HSA Registration DE0503129

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.

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CLASS B
DE0503129
Coloplast DORMIA® No-Tip and N.stone extractor
HSA Registration Number: DE0503129
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Product Description

Extraction of urinary tract calculi.

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 Owner
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