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LiNA LiNA OperaScope - HSA Registration DE0508450

Access comprehensive regulatory information for LiNA LiNA OperaScope in the Singapore medical device market through Pure Global AI's free database. This CLASS B medical device is registered under HSA registration number DE0508450 and owned by LiNA Medical ApS. The device was registered on September 04, 2023.

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
DE0508450
LiNA LiNA OperaScope
HSA Registration Number: DE0508450
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Product Description

LiNA OperaScope™ for Hysteroscopy:The LiNA OperaScope™ is intended for use in visualization of the cervical canal and uterine cavity during diagnostic and therapeutic gynecological procedures. LiNA OperaScope™ for Cystoscopy: The LiNA OperaScope™ is intended for use in visualization of the female urethra and the bladder cavity during diagnostic and therapeutic cystoscopic procedures.

Device Classification
Device Class
CLASS B
Medical Speciality Area
Obstetrics & Gynaecology
Registration Information
Registration Number
DE0508450
Registration Date
September 04, 2023
Retention Due Date
September 03, 2025
Product Owner
Short Name
LiNA Medical ApS
Address
Formervangen 5 2600 Glostrup, DENMARK
Registrant
Address
100H PASIR PANJANG ROAD, OC@PASIR PANJANG, #07-01, SINGAPORE 118524
Importer
Address
100H PASIR PANJANG ROAD, OC@PASIR PANJANG, #07-01, SINGAPORE 118524
Model Information
Model Name(s)
LiNA OperaScope with HDMI cable & LCD LiNA OperaScope Biopsy Forceps LiNA OperaScope Rat Tooth Alligator Grasper OP-LAS10-3-I LiNA OperaScope Lasso OP-LAS10-3-I LiNA OperaScope Lasso LiNA OperaScope Scissors LiNA OperaScope Tubing and Drape Kit
Model Identifier(s)
OP-201-6-I OP-FCP-6-I OP-GRA-6-I OP-LAS10-3-I OP-LAS16-3-I OP-SCI-3-I OP-TDK-6-I