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CIVCO Starter kit with Latex covers - HSA Registration DE0507997

Access comprehensive regulatory information for CIVCO Starter kit with Latex covers in the Singapore medical device market through Pure Global AI's free database. This CLASS B medical device is registered under HSA registration number DE0507997 and owned by CIVCO Medical Instruments Co., Inc.. The device was registered on April 13, 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
DE0507997
CIVCO Starter kit with Latex covers
HSA Registration Number: DE0507997
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Product Description

The device is intended to provide physicians with tools for electromagnetic tracking of instruments with respect to image data.

Device Classification
Device Class
CLASS B
Medical Speciality Area
General Hospital
Registration Information
Registration Number
DE0507997
Registration Date
April 13, 2023
Retention Due Date
April 12, 2026
Product Owner
Short Name
CIVCO Medical Instruments Co., Inc.
Address
102 First Street South, Kalona, IA, 52247, UNITED STATES
Registrant
Address
10 UBI CRESCENT, UBI TECHPARK, #05-18, SINGAPORE 408564
Importer
Address
10 UBI CRESCENT, UBI TECHPARK, #05-18, SINGAPORE 408564
Model Information
Model Name(s)
Tracking Bracket Tracking Bracket Kit
Model Identifier(s)
667-146 667-147