Pure Global

PaloDEx Scan eXam ® Intraoral Digital Imaging Plate System - HSA Registration DE0500259

Access comprehensive regulatory information for PaloDEx Scan eXam ® Intraoral Digital Imaging Plate 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 DE0500259 and owned by PaloDEx Group Oy. The device was registered on October 14, 2014.

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
DE0500259
PaloDEx Scan eXam ® Intraoral Digital Imaging Plate System
HSA Registration Number: DE0500259
Pure Global
DJ Fang

DJ Fang

MedTech Regulatory Expert

Need help with 30+ markets registration?

Pricing
Product Description

PaloDex Scan eXam® Intraoral Digital Imaging Plate System is intended to automatically read reusable dental intraoral imaging plate size 0, 1, 2, and 3. After reading the images can be viewed on the PC using the dental imaging software CLINIVIEW™.

Device Classification
Device Class
CLASS B
Medical Speciality Area
Dental
Registration Information
Registration Number
DE0500259
Registration Date
October 14, 2014
Change Notification Approval Date
December 01, 2022
Retention Due Date
October 13, 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)
Scan eXam® (Type: eXam5-1) Hygiene Bag Size 0 x 200 pcs Hygiene Bag Size 1 x 200 pcs Hygiene Bag Size 2 x 200 pcs Hygiene Bag Size 3 x 200 pcs STD Imaging Plate Set Size 0 x 6 pcs STD Imaging Plate Set Size 1 x 6 pcs STD Imaging Plate Set Size 2 x 6 pcs STD Imaging Plate Set Size 3 x 6 pcs IDOT Imaging Plate Set Size 0 x 6 pcs IDOT Imaging Plate Set Size 1 x 6 pcs IDOT Imaging Plate Set Size 2 x 6 pcs IDOT Imaging Plate Set Size 3 x 6 pcs Protective Cover Size 0 x 200 pcs Protective Cover Size 1 x 200 pcs Protective Cover Size 2 x 200 pcs Protective Cover Size 3 x 200 pcs STD Imaging Plate Start-up Set IDOT Imaging Plate Start-up Set Hawe Imaging Plate Holder test set Protective Cover Kit Size 1, 2 Hygiene Bag Kit Size 1, 2 Hygiene Bag Size 0 Hygiene Bag Size 1 Hygiene Bag Size 2 Hygiene Bag Size 3 STD Imaging Plate Set Size 0 STD Imaging Plate Set Size 1 STD Imaging Plate Set Size 2 STD Imaging Plate Set Size 3 IDOT Imaging Plate Set Size 0 IDOT Imaging Plate Set Size 1 IDOT Imaging Plate Set Size 2 IDOT Imaging Plate Set Size 3 Protective Cover Size 0 Protective Cover Size 1 Protective Cover Size 2 Protective Cover Size 3 STD Imaging Plate Start-up Set IDOT Imaging Plate Start-up Set Occlusal 4C Start-up Kit Occlusal 4C Refill Kit Occlusal 4C Hygiene Bag 100 pcs Scan eXam® (Type: eXam5-1)
Model Identifier(s)
0.805.0200 0.805.0211 0.805.0212 0.805.0213 0.805.0214 0.805.0215 0.805.0216 0.805.0217 0.805.0218 0.805.0219 0.805.0220 0.805.0221 0.805.0222 0.805.0223 0.805.0224 0.805.0225 0.805.0226 0.805.0227 0.805.0228 900170 900368-DEX 900369-DEX 900475-DEX 900476-DEX 900477-DEX 900478-DEX 900479-PTU 900480-PTU 900481-PTU 900482-PTU 900483-PTU 900484-PTU 900485-PTU 900486-PTU 900487-DEX 900488-DEX 900489-DEX 900490-DEX 900491 900492 900801-DEX 900802-DEX 900803-DEX 901009