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PaloDEx DEXIS Scan eXam™ One Digital Intraoral Imaging Plate System - HSA Registration DE0016695

Access comprehensive regulatory information for PaloDEx DEXIS Scan eXam™ One Digital Intraoral 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 DE0016695 and owned by PaloDEx Group Oy. The device was registered on December 26, 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.

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CLASS B
DE0016695
PaloDEx DEXIS Scan eXam™ One Digital Intraoral Imaging Plate System
HSA Registration Number: DE0016695
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Product Description

System is intended to be used only by dentist and other qualified dental professionals to process x-ray images exposed to the imaging plates from the intraoral complex of the skull.

Device Classification
Device Class
CLASS B
Medical Speciality Area
Dental
Registration Information
Registration Number
DE0016695
Registration Date
December 26, 2014
Change Notification Approval Date
December 16, 2022
Retention Due Date
December 25, 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)
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 Scan eXam™ One (Type: eXam6-1) Occlusal 4C Start-up Kit Occlusal 4C Accessory Kit Occlusal 4C Hygiene Bag 100 pcs Protective Cover Kit Size 1, 2 Hygiene Bag Kit Size 1, 2
Model Identifier(s)
0.805.0211 (900475-DEX) 0.805.0212 (900476-DEX) 0.805.0213 (900477-DEX) 0.805.0214 (900478-DEX) 0.805.0215 (900479-PTU) 0.805.0216 (900480-PTU) 0.805.0217 (900481-PTU) 0.805.0218 (900482-PTU) 0.805.0219 (900483-PTU) 0.805.0220 (900484-PTU) 0.805.0221 (900485-PTU) 0.805.0222 (900486-PTU) 0.805.0223 (900487-DEX) 0.805.0224 (900488-DEX) 0.805.0225 (900489-DEX) 0.805.0226 (900490-DEX) 0.805.3470 (900687-PTU) 0.805.3480 (900801-DEX) 0.805.3481 (900802-DEX) 0.805.3482 (900803-DEX) 900368-DEX 900369-DEX