Singapore HSA registration DE0508809
Medtronic PTeye™ Parathyroid Detection System
Singapore·CLASS B·Medtronic Xomed·Registered January 04, 2024Device 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 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.
Product Owner
- Name
- Medtronic Xomed
- 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
About this record
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.
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