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Covidien TruClear Elite hysteroscopes - HSA Registration DE0503150

Access comprehensive regulatory information for Covidien TruClear Elite hysteroscopes in the Singapore medical device market through Pure Global AI's free database. This CLASS B medical device is registered under HSA registration number DE0503150 and owned by Covidien llc. The device was registered on May 27, 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
DE0503150
Covidien TruClear Elite hysteroscopes
HSA Registration Number: DE0503150
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Product Description

TruClear Elite hysteroscopes are used to permit viewing of the cervical canal and the uterine cavity for the purpose of performing diagnostic and operative procedures.

Device Classification
Device Class
CLASS B
Medical Speciality Area
Obstetrics & Gynaecology
Registration Information
Registration Number
DE0503150
Registration Date
May 27, 2019
Change Notification Approval Date
May 14, 2025
Retention Due Date
May 26, 2025
Product Owner
Short Name
Covidien llc
Address
15 Hampshire Street Mansfield, MA 02048, UNITED STATES
Registrant
Address
50 PASIR PANJANG ROAD, MAPLETREE BUSINESS CITY, #04-51, SINGAPORE 117384
Importer
Address
50 PASIR PANJANG ROAD, MAPLETREE BUSINESS CITY, #04-51, SINGAPORE 117384
Model Information
Model Name(s)
TruClear Elite hysteroscope Mini (includes insert) TruClear Elite hysteroscope Plus (includes insert) TruClear Elite hysteroscope seal TruClear Elite working channel insert Mini, 3mm TruClear Elite working channel insert Plus, 4mm TruClear Elite stopcock replacement set TruClear Elite retaining cap
Model Identifier(s)
72204878 72204879 72205051 72205066 72205067 90505000 90505001