Singapore HSA registration DE0016695
PaloDEx DEXIS Scan eXam™ One Digital Intraoral Imaging Plate System
Singapore·CLASS B·PaloDEx Group Oy·Registered December 26, 2014Device 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 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.
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)
- 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
About this record
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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