Singapore HSA registration DE0017771
Palodex Orthopantomograph™ OP300 Digital Imaging Systems
Singapore·CLASS C·PaloDEx Group Oy·Registered January 12, 2016Device classification
- Device Class
- CLASS C
- Medical Speciality Area
- Dental
Registration information
- Registration Number
- DE0017771
- Registration Date
- January 12, 2016
- Change Notification Approval Date
- December 15, 2022
- Retention Due Date
- January 11, 2026
Product description
OP300 must only be used and operated by healthcare professionals and other qualified professionals. OP300 must only be used to take panoramic, cephalometric and 3D images of the dento-maxillofacial complex of the human skull. It must not be used to take images of any other part of the human body. Panoramic and 3D exposures should not be used if conventional intraoral radiographic images (like biteviewing exposures) would be sufficient. Cone beam computed tomography images are not adequate for the analysis of soft tissue.
Product Owner
- Name
- PaloDEx Group Oy
- Short Name
- PaloDEx Group Oy
- Address
- Nahkelantie 160, FI-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)
- ORTHOPANTOMOGRAPH OP 3D Pro panoramic ORTHOPANTOMOGRAPH OP 3D Pro with ceph ORTHOPANTOMOGRAPH OP 3D Pro with 3D small panel ORTHOPANTOMOGRAPH OP 3D Pro with ceph and 3D small panel ORTHOPANTOMOGRAPH OP 3D Pro with Maxio ORTHOPANTOMOGRAPH OP 3D Pro with Maxio and ceph Ceph Upgrade Kit For OP 3D Pro MFOV Upgrade Kit for OP 3D Pro Pan OP300 Tubehead (Type: NGEO) OP300 Sensor C10901D (Type: NGEO-3D-S) OP300 Cephalo Bld (toisiorajain) (Type: BLD-NGEO-C) OP300 Collimator (Type: BLD-NGEO-S-2) OP300 Collimator (Type: BLD-NGEO-M) OP300 Sensor 3D Med (Type: NGEO-3D-M) OP 3D PRO PAN SENSOR OP 3D PRO CEPH SENSOR
- Model Identifier(s)
- 901001 901002 901003 901004 901005 901006 901033 901035 SP00448 SP00515 SP00725 SP00975 SP01025 SP01032 SP01303 SP01307
About this record
Access comprehensive regulatory information for Palodex Orthopantomograph™ OP300 Digital Imaging Systems in the Singapore medical device market through Pure Global AI's free database. This CLASS C medical device is registered under HSA registration number DE0017771 and owned by PaloDEx Group Oy. The device was registered on January 12, 2016.
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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