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CIVCO TP Pivot Proโ„ข Transperineal Biopsy Needle Guide - HSA Registration DE0510016

Access comprehensive regulatory information for CIVCO TP Pivot Proโ„ข Transperineal Biopsy Needle Guide in the Singapore medical device market through Pure Global AI's free database. This CLASS B medical device is registered under HSA registration number DE0510016 and owned by CIVCO Medical Instruments Co., Inc dba CIVCO and CIVCO Medical Solutions. The device was registered on November 07, 2024.

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
DE0510016
CIVCO TP Pivot Proโ„ข Transperineal Biopsy Needle Guide
HSA Registration Number: DE0510016
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Product Description

Device is intended to be used for instrument placement to access anatomical structures under transrectal ultrasound guidance.

Device Classification
Device Class
CLASS B
Medical Speciality Area
Gastroenterology & Urology
Registration Information
Registration Number
DE0510016
Registration Date
November 07, 2024
Retention Due Date
November 06, 2025
Product Owner
Short Name
CIVCO Medical Instruments Co., Inc dba CIVCO and CIVCO Medical Solutions
Address
102, First Street South, Kalona IA 52247, UNITED STATES
Registrant
Address
28 SIN MING LANE, MIDVIEW CITY, #02-143, SINGAPORE 573972
Importer
Address
28 SIN MING LANE, MIDVIEW CITY, #02-143, SINGAPORE 573972
Model Information
Model Name(s)
Needle Guide Needle Guide Needle Guide
Model Identifier(s)
610-1553 610-1554 610-1556