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MEDICEM Dilapan- S Hygroscopic Cervical Dilator - HSA Registration DE0008111

Access comprehensive regulatory information for MEDICEM Dilapan- S Hygroscopic Cervical Dilator in the Singapore medical device market through Pure Global AI's free database. This CLASS B medical device is registered under HSA registration number DE0008111 and owned by MEDICEM Technology s.r.o.. The device was registered on December 05, 2011.

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
DE0008111
MEDICEM Dilapan- S Hygroscopic Cervical Dilator
HSA Registration Number: DE0008111
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Product Description

The DILAPAN-Sยฎ is for use wherever cervical softening and dilation are desired, such as cervical ripening prior to labour induction, cervical preparation prior to termination of pregnancy or other instrumentation inside the uterine cavity.

Device Classification
Device Class
CLASS B
Medical Speciality Area
Obstetrics & Gynaecology
Registration Information
Registration Number
DE0008111
Registration Date
December 05, 2011
Change Notification Approval Date
November 26, 2019
Retention Due Date
December 31, 2025
Product Owner
Address
Karlovarskรก 20, 273 01 Kamennรฉ ลฝehrovice, CZECH REPUBLIC
Registrant
Address
371 BEACH ROAD, KEYPOINT, SINGAPORE 199597
Importer
Address
47 JALAN BUROH, #09-01, SINGAPORE 619491
Model Information
Model Name(s)
Dilapan-S The Hygroscopic Cervical Dilator Dilapan-S The Hygroscopic Cervical Dilator Dilapan-S The Hygroscopic Cervical Dilator
Model Identifier(s)
3mm x 55mm 4mm x 55mm 4mm x 65mm