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Singapore HSA registration DE0505821

Coloplast ImaJin™ Hydro-Coated Silicone Double Loop Ureteral Stent Kit

Singapore flagSingapore·CLASS C·Coloplast A/S·Registered May 25, 2021
Device classification
Device Class
CLASS C
Medical Speciality Area
General Hospital
Registration information
Registration Number
DE0505821
Registration Date
May 25, 2021
Change Notification Approval Date
September 30, 2024
Retention Due Date
May 24, 2026
Product description
- Drainage of the upper urinary tract over fistulas or ureteral obstacles (e.g.: periureteral tumour) - Healing of the ureter
Product Owner
Name
Coloplast A/S
Short Name
Coloplast A/S
Address
Holtedam 1, 3050 Humlebaek, DENMARK
Registrant
Name
COLOPLAST A/S SINGAPORE BRANCH
Address
10 ANSON ROAD, INTERNATIONAL PLAZA, #15-18, SINGAPORE 079903
Importer
Name
MEDICONSULT ASIA PTE. LTD.
Address
40 JALAN PEMIMPIN, TAT ANN BUILDING, #03-01C, SINGAPORE 577185
Model information
Model Name(s)
ImaJin™ Hydro-Coated silicone double loop ureteral stent kit ImaJin™ Hydro-Coated silicone double loop ureteral stent kit ImaJin™ Hydro-Coated silicone double loop ureteral stent kit ImaJin™ Hydro-Coated silicone double loop ureteral stent kit ImaJin™ Hydro-Coated silicone double loop ureteral stent kit ImaJin™ Hydro-Coated silicone double loop ureteral stent kit ImaJin™ Hydro-Coated silicone double loop ureteral stent kit ImaJin™ Hydro-Coated silicone double loop ureteral stent kit ImaJin™ Hydro-Coated silicone double loop ureteral stent kit ImaJin™ Hydro-Coated silicone double loop ureteral stent kit ImaJin™ Hydro-Coated silicone double loop ureteral stent kit ImaJin™ Hydro-Coated silicone double loop ureteral stent kit ImaJin™ Hydro-Coated silicone double loop ureteral stent kit ImaJin™ Hydro-Coated silicone double loop ureteral stent kit ImaJin™ Hydro-Coated silicone double loop ureteral stent kit ImaJin™ Hydro-Coated silicone double loop ureteral stent kit ImaJin™ Hydro-Coated silicone double loop ureteral stent kit ImaJin™ Hydro-Coated silicone double loop ureteral stent kit ImaJin™ Hydro-Coated silicone double loop ureteral stent kit ImaJin™ Hydro-Coated silicone double loop ureteral stent kit
Model Identifier(s)
BCHJ61 BCHJ62 BCHJ63 BCHJ64 BCHJ65 BCHJ66 BCHJ67 BCHJ71 BCHJ72 BCHJ73 BCHJ74 BCHJ75 BCHJ76 BCHJ77 BCHJ81 BCHJ82 BCHJ83 BCHJ84 BCHJ85 BCHJ86
About this record

Access comprehensive regulatory information for Coloplast ImaJin™ Hydro-Coated Silicone Double Loop Ureteral Stent Kit in the Singapore medical device market through Pure Global AI's free database. This CLASS C medical device is registered under HSA registration number DE0505821 and owned by Coloplast A/S. The device was registered on May 25, 2021.

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 C