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HSA · registration DE0503150

Covidien TruClear Elite hysteroscopes

SingaporeObstetrics & GynaecologyClass BCovidien llc
Verified
Official record identity
Registration number
DE0503150
Model name
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
72204878; 72204879; 72205051; 72205066; 72205067; 90505000; 90505001
Registration date
May 27, 2019
Source update date
April 16, 2026
Classification
Risk class
Class B
Official value: CLASS B
Published category
Obstetrics & Gynaecology
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Published parties
Product owner
Covidien llc
Registrant / registration holder
COVIDIEN PRIVATE LIMITED
Official 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.

Additional source fields
Product owner address
15 Hampshire Street Mansfield, MA 02048, United States
Registrant address
50 PASIR PANJANG ROAD, #04-51, MAPLETREE BUSINESS CITY, Singapore 117384
About this record

This page mirrors one row from HSA’s official registered-medical-device workbook. Product owner and registrant are separate published roles; neither is relabeled as the manufacturer. The official NOT_GENERATED value is retained when HSA does not publish a registration number, and the device name remains part of the stable record identity.