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PaloDEx ORTHOPANTOMOGRAPH™ OP 3D Digital Imaging System - HSA Registration DE0019416

Access comprehensive regulatory information for PaloDEx ORTHOPANTOMOGRAPH™ OP 3D Digital Imaging System in the Singapore medical device market through Pure Global AI's free database. This CLASS C medical device is registered under HSA registration number DE0019416 and owned by PaloDEx Group Oy. The device was registered on July 17, 2017.

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 C
DE0019416
PaloDEx ORTHOPANTOMOGRAPH™ OP 3D Digital Imaging System
HSA Registration Number: DE0019416
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Product Description

PaloDEx ORTHOPANTOMOGRAPH™ OP 3D is an x-ray device that is intended to be used for imaging of adult and pediatric patients. The device can be configured to take panoramic, cephalometric, or 3D images of the cranio-maxillofacial complex for use in diagnostic support. The device can also be configured to take carpus images. PaloDEx ORTHOPANTOMOGRAPH™ OP 3D must only be used and operated by dentist and other qualified professionals.

Device Classification
Device Class
CLASS C
Medical Speciality Area
Radiology / Imaging
Registration Information
Registration Number
DE0019416
Registration Date
July 17, 2017
Change Notification Approval Date
May 02, 2024
Retention Due Date
July 16, 2025
Product Owner
Short Name
PaloDEx Group Oy
Address
Nahkelantie 160, 04300 Tuusula, FINLAND
Registrant
Address
7500A BEACH ROAD, THE PLAZA, #09-303, SINGAPORE 199591
Importer
Address
13 STAMFORD ROAD, CAPITOL PIAZZA, #02-11, SINGAPORE 178905 13 STAMFORD ROAD, CAPITOL PIAZZA, #02-11, SINGAPORE 178905 73 UBI ROAD 1, OXLEY BIZHUB, #10-61/62, SINGAPORE 408733
Model Information
Model Name(s)
Chin Support Disposable Cover Bite Block Disposable Cover Nasion Support Disposable Cover Ear Holder Covers ORTHOPANTOMOGRAPH™ OP 3D Pan ORTHOPANTOMOGRAPH™ OP 3D PanCeph ORTHOPANTOMOGRAPH™ OP 3D Pan 3D ORTHOPANTOMOGRAPH™ OP 3D PanCeph3D Lip Support Disposable Cover OP 3D 9X14 FOV UPGRADE CEPH UPGRADE KIT FOR OP 3D 3D UPPGRADE KIT FOR OP 3D OP 3D Collimator OP 3D Tubehead OP 3D Sensor
Model Identifier(s)
900509 900510 900511 900638 (208224) 900989 900990 900991 900992 901011 901012 901084 901085 SP01217 SP01243 SP01297