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CooperSurgical Milex Silicone Pessaries - HSA Registration DE0509546

Access comprehensive regulatory information for CooperSurgical Milex Silicone Pessaries in the Singapore medical device market through Pure Global AI's free database. This CLASS C medical device is registered under HSA registration number DE0509546 and owned by CooperSurgical, Inc.. The device was registered on July 18, 2024.

This page provides complete registration details including product owner information, registrant details, 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 C
DE0509546
CooperSurgical Milex Silicone Pessaries
HSA Registration Number: DE0509546
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Product Description

The Milexยฎ Pessaries are a medical device made from silicone that is inserted into the vagina to function as a supportive structure of the uterus, bladder and or rectum. Hodge pessary is indicated for stress urinary incontinence. It is also indicated for uterine retrodisplacement with accompanying symptoms of backache and/or dysmenorrhea. The RING with KNOB pessary is indicated for stress urinary incontinence complicated by Stage I or Stage II uterine prolapse. Incontinence dish and ring flexible pessaries are indicated for stress urinary incontinence. The RING pessary is indicated for support in Stage I and Stage II prolapse. The GEHRUNG pessary provides effective support in cases of cystocele. It can also be manually shaped to reduce a rectocele. The GELLHORN pessary and donut pessary provide effective support of third-degree prolapse or procidentia.

Device Classification
Device Class
CLASS C
Medical Speciality Area
General Hospital
Registration Information
Registration Number
DE0509546
Registration Date
July 18, 2024
Retention Due Date
July 17, 2025
Product Owner
Short Name
CooperSurgical, Inc.
Address
95 Corporate Drive Trumbull, Connecticut, 06611, UNITED STATES
Registrant
Address
1 TAMPINES NORTH DRIVE 1, T-SPACE, #06-08, SINGAPORE 528559
Model Information
Model Name(s)
Milex Incontinence Ring Flexible Pessary Milex Incontinence Ring Flexible Pessary Milex Incontinence Ring Flexible Pessary Milex Incontinence Ring Flexible Pessary Milex Incontinence Ring Flexible Pessary Milex Incontinence Ring Flexible Pessary Milex Incontinence Ring Flexible Pessary Milex Incontinence Ring Flexible Pessary Milex Incontinence Ring Flexible Pessary Milex Incontinence Ring Flexible Pessary Milex Incontinence Ring Flexible Pessary Milex Incontinence Ring Flexible Pessary Milex Incontinence Ring Flexible Pessary Milex Incontinence Ring Flexible Pessary Milex Incontinence Dish Folding Pessary Milex Incontinence Dish Folding Pessary Milex Incontinence Dish Folding Pessary Milex Incontinence Dish Folding Pessary Milex Incontinence Dish Folding Pessary Milex Incontinence Dish Folding Pessary Milex Incontinence Dish Folding Pessary Milex Incontinence Dish Folding Pessary Milex Incontinence Dish Folding Pessary Milex Incontinence Dish Folding Pessary Milex Incontinence Dish Folding Pessary Milex Incontinence Dish Folding Pessary Milex Incontinence Dish Folding Pessary Milex Incontinence Dish Folding Pessary Milex Donut Pessary Milex Donut Pessary Milex Donut Pessary Milex Donut Pessary Milex Donut Pessary Milex Donut Pessary Milex Donut Pessary Milex Donut Pessary Milex Hodge Folding Pessary Milex Hodge Folding Pessary Milex Hodge Folding Pessary Milex Hodge Folding Pessary Milex Hodge Folding Pessary Milex Hodge Folding Pessary Milex Hodge Folding Pessary Milex Hodge Folding Pessary Milex Hodge Folding Pessary Milex Hodge Folding Pessary Milex Ring Folding Pessary Milex Ring Folding Pessary Milex Ring Folding Pessary Milex Ring Folding Pessary Milex Ring Folding Pessary Milex Ring Folding Pessary Milex Ring Folding Pessary Milex Ring Folding Pessary Milex Ring Folding Pessary Milex Ring Folding Pessary Milex Ring Folding Pessary Milex Ring Folding Pessary Milex Ring Folding Pessary Milex Ring Folding Pessary Milex Ring w/Knob Folding Pessary Milex Ring w/Knob Folding Pessary Milex Ring w/Knob Folding Pessary Milex Ring w/Knob Folding Pessary Milex Ring w/Knob Folding Pessary Milex Ring w/Knob Folding Pessary Milex Ring w/Knob Folding Pessary Milex Ring w/Knob Folding Pessary Milex Ring w/Knob Folding Pessary Milex Ring w/Knob Folding Pessary Milex Ring w/Knob Folding Pessary Milex Ring w/Knob Folding Pessary Milex Ring w/Knob Folding Pessary Milex Ring w/Knob Folding Pessary Milex Gellhorn Flexible Pessary Milex Gellhorn Flexible Pessary Milex Gellhorn Flexible Pessary Milex Gellhorn Flexible Pessary Milex Gellhorn Flexible Pessary Milex Gellhorn Flexible Pessary Milex Gellhorn Flexible Pessary Milex Gellhorn Flexible Pessary Milex Gellhorn Flexible Pessary Milex Gellhorn Flexible Pessary Milex Gehrung Folding Pessary Milex Gehrung Folding Pessary Milex Gehrung Folding Pessary Milex Gehrung Folding Pessary Milex Gehrung Folding Pessary Milex Gehrung Folding Pessary Milex Gehrung Folding Pessary Milex Gehrung Folding Pessary Milex Gehrung Folding Pessary Milex Gehrung Folding Pessary Milex Gehrung w/Knob Folding Pessary Milex Gehrung w/Knob Folding Pessary Milex Gehrung w/Knob Folding Pessary Milex Gehrung w/Knob Folding Pessary Milex Gehrung w/Knob Folding Pessary Milex Gehrung w/Knob Folding Pessary Milex Gehrung w/Knob Folding Pessary Milex Gehrung w/Knob Folding Pessary Milex Gehrung w/Knob Folding Pessary Milex Gehrung w/Knob Folding Pessary Milex Gellhorn Flexible Pessary Milex Gellhorn Flexible Pessary Milex Gellhorn Flexible Pessary Milex Gellhorn Flexible Pessary Milex Gellhorn Flexible Pessary Milex Gellhorn Flexible Pessary Milex Gellhorn Flexible Pessary Milex Gellhorn Flexible Pessary Milex Gellhorn Flexible Pessary Milex Gellhorn Flexible Pessary Milex Ring Folding Pessary Milex Ring Folding Pessary Milex Ring Folding Pessary Milex Ring Folding Pessary Milex Ring Folding Pessary Milex Ring Folding Pessary Milex Ring Folding Pessary Milex Ring Folding Pessary Milex Ring Folding Pessary Milex Ring Folding Pessary Milex Ring Folding Pessary Milex Ring Folding Pessary Milex Ring Folding Pessary Milex Ring Folding Pessary Milex Ring w/Support w/Knob Folding Pessary Milex Ring w/Support w/Knob Folding Pessary Milex Ring w/Support w/Knob Folding Pessary Milex Ring w/Support w/Knob Folding Pessary Milex Ring w/Support w/Knob Folding Pessary Milex Ring w/Support w/Knob Folding Pessary Milex Ring w/Support w/Knob Folding Pessary Milex Ring w/Support w/Knob Folding Pessary Milex Ring w/Support w/Knob Folding Pessary Milex Ring w/Support w/Knob Folding Pessary Milex Ring w/Support w/Knob Folding Pessary Milex Ring w/Support w/Knob Folding Pessary Milex Ring w/Support w/Knob Folding Pessary Milex Ring w/Support w/Knob Folding Pessary Milex Shaatz Folding Pessary Milex Shaatz Folding Pessary Milex Shaatz Folding Pessary Milex Shaatz Folding Pessary Milex Shaatz Folding Pessary Milex Shaatz Folding Pessary Milex Shaatz Folding Pessary Milex Shaatz Folding Pessary Milex Shaatz Folding Pessary Milex Shaatz Folding Pessary
Model Identifier(s)
MXPCON00 MXPCON01 MXPCON02 MXPCON03 MXPCON04 MXPCON05 MXPCON06 MXPCON07 MXPCON08 MXPCON09 MXPCON10 MXPCON11 MXPCON12 MXPCON13 MXPCOND00 MXPCOND01 MXPCOND02 MXPCOND03 MXPCOND04 MXPCOND05 MXPCOND06 MXPCONDS00 MXPCONDS01 MXPCONDS02 MXPCONDS03 MXPCONDS04 MXPCONDS05 MXPCONDS06 MXPDO0 MXPDO01 MXPDO02 MXPDO03 MXPDO04 MXPDO05 MXPDO06 MXPDO07 MXPEH00 MXPEH01 MXPEH02 MXPEH03 MXPEH04 MXPEH05 MXPEH06 MXPEH07 MXPEH08 MXPEH09 MXPER00 MXPER01 MXPER02 MXPER03 MXPER04 MXPER05 MXPER06 MXPER07 MXPER08 MXPER09 MXPER10 MXPER11 MXPER12 MXPER13 MXPERK00 MXPERK01 MXPERK02 MXPERK03 MXPERK04 MXPERK05 MXPERK06 MXPERK07 MXPERK08 MXPERK09 MXPERK10 MXPERK11 MXPERK12 MXPERK13 MXPGE1-1/2 MXPGE1-3/4 MXPGE2- MXPGE2-1/2 MXPGE2-1/4 MXPGE2-3/4 MXPGE3- MXPGE3-1/2 MXPGE3-1/4 MXPGE3-3/4 MXPGS00 MXPGS01 MXPGS02 MXPGS03 MXPGS04 MXPGS05 MXPGS06 MXPGS07 MXPGS08 MXPGS09 MXPGSK00 MXPGSK01 MXPGSK02 MXPGSK03 MXPGSK04 MXPGSK05 MXPGSK06 MXPGSK07 MXPGSK08 MXPGSK09 MXPGSS1-1/2 MXPGSS1-3/4 MXPGSS2- MXPGSS2-1/2 MXPGSS2-1/4 MXPGSS2-3/4 MXPGSS3- MXPGSS3-1/2 MXPGSS3-1/4 MXPGSS3-3/4 MXPRS00 MXPRS01 MXPRS02 MXPRS03 MXPRS04 MXPRS05 MXPRS06 MXPRS07 MXPRS08 MXPRS09 MXPRS10 MXPRS11 MXPRS12 MXPRS13 MXPRSK00 MXPRSK01 MXPRSK02 MXPRSK03 MXPRSK04 MXPRSK05 MXPRSK06 MXPRSK07 MXPRSK08 MXPRSK09 MXPRSK10 MXPRSK11 MXPRSK12 MXPRSK13 MXPSH1-1/2 MXPSH1-3/4 MXPSH2- MXPSH2-1/2 MXPSH2-1/4 MXPSH2-3/4 MXPSH3- MXPSH3-1/2 MXPSH3-1/4 MXPSH3-3/4