Singapore HSA registration DE0503150
Covidien TruClear Elite hysteroscopes
Singapore·CLASS B·Covidien llc·Registered May 27, 2019Device 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 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.
Product Owner
- Name
- Covidien llc
- 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
About this record
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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