Pure Global

Medtronic PTeye™ Parathyroid Detection System - HSA Registration DE0508809

Access comprehensive regulatory information for Medtronic PTeye™ Parathyroid Detection System in the Singapore medical device market through Pure Global AI's free database. This CLASS B medical device is registered under HSA registration number DE0508809 and owned by Medtronic Xomed. The device was registered on January 04, 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.

Free Database
Powered by Pure Global AI
HSA Official Data
CLASS B
DE0508809
Medtronic PTeye™ Parathyroid Detection System
HSA Registration Number: DE0508809
Pure Global
DJ Fang

DJ Fang

MedTech Regulatory Expert

Need help with 30+ markets registration?

Pricing
Product Description

The PTeye™ system is an adjunctive tool intended to aid in the identification of parathyroid tissue by confirming parathyroid tissue already visually located by the surgeon in adults 18 years of age and older. The PTeye™ system is for prescription use. The intended end-user of the PTeye™ device is any surgeon performing thyroid or parathyroid procedures who desires an aid for parathyroid identification. The intended environment of use is any OR theater where thyroid or parathyroid procedures are being performed.

Device Classification
Device Class
CLASS B
Medical Speciality Area
Ear, Nose & Throat
Registration Information
Registration Number
DE0508809
Registration Date
January 04, 2024
Retention Due Date
January 03, 2026
Product Owner
Short Name
Medtronic Xomed
Address
6743 Southpoint Drive North, Jacksonville, Florida 32216, UNITED STATES
Registrant
Address
50 PASIR PANJANG ROAD, MAPLETREE BUSINESS CITY, #04-51, SINGAPORE 117384
Importer
Address
50 PASIR PANJANG ROAD, MAPLETREE BUSINESS CITY, #04-51, SINGAPORE 117384 50 PASIR PANJANG ROAD, MAPLETREE BUSINESS CITY, #04-51, SINGAPORE 117384
Model Information
Model Name(s)
PTeye™ Console PTeye™ Probe
Model Identifier(s)
PTEYE PTEYE-1