Singapore HSA registration DE0019416
PaloDEx ORTHOPANTOMOGRAPH™ OP 3D Digital Imaging System
Singapore·CLASS C·PaloDEx Group Oy·Registered July 17, 2017Device 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 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.
Product Owner
- Name
- PaloDEx Group Oy
- Short Name
- PaloDEx Group Oy
- Address
- Nahkelantie 160, 04300 Tuusula, FINLAND
Registrant
- Name
- EHC SUPPLY
- 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
About this record
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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