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Singapore HSA registration DE0509788

SATELEC NEWTRON P5 XS / XS B.LED DENTAL ULTRASONIC CONSOLE

Singapore flagSingapore·CLASS B·SATELEC, A company of ACTEONGROUP·Registered September 17, 2024
Device classification
Device Class
CLASS B
Medical Speciality Area
Dental
Registration information
Registration Number
DE0509788
Registration Date
September 17, 2024
Retention Due Date
September 16, 2025
Product description
This medical device in System is used with a Dental Ultrasonic Handpiece to which an ultrasonic instrument is attached. It is designed for the treatment of prophylaxis periodontics, endodontics and preservation and restoration dentistry.
Product Owner
Name
SATELEC, A company of ACTEONGROUP
Short Name
SATELEC, A company of ACTEONGROUP
Address
17 av. Gustave Eiffel, ZI du Phare, 33700 MERIGNAC FRANCE, FRANCE
Registrant
Name
HEALTHBIZ RESOURCE PTE. LTD.
Address
5 ANG MO KIO INDUSTRIAL PARK 2A, AMK TECH II, #05-21, SINGAPORE 567760
Importer
Name
HEALTHBIZ RESOURCE PTE. LTD.
Address
5 ANG MO KIO INDUSTRIAL PARK 2A, AMK TECH II, #05-21, SINGAPORE 567760
Model information
Model Name(s)
FOOTSWITCH WITH CABLE AS3D AS9D AS6D ASLD ASRD P2L P2R P14D P15LD P15RD C20 H4L H4R S12-70D 1S 1 2 3 5AE 10P 10Z 10X H1 H2L H2R H3 FLAT WRENCH PH1 PH2L PH2R TK1-1S TK1-1L IP1 IP2L IP2R IP3L IP3R TK2-1R TK2-1L PFU PFL PFR PM1 PM2 PM3 PM4 NEWTRON SLIM B.LED BLUE HP NEWTRON SLIM B.LED WHITE HP K10/21 K10/25 K15/21 K15/25 K25/21 K25/25 K30/21 K30/25 IRR 25/21 IRR 25/25 IRR 20/21 IRR 20/25 TANK 300ML NEWT P5XS TANK 500ML NEWT P5XS NEWTRON P5 XS B.LED NEWTRON P5 XS PURE SO4 ET20 ET40 ET20D ET40D ET18D ET25 ETPR ETBD ET25S ET25L CAP1 CAP2 CAP3
Model Identifier(s)
F00044 F00065 F00067 F00079 F00080 F00081 F00090 F00091 F00106 F00107 F00108 F00113 F00114 F00115 F00118 F00245 F00246 F00247 F00248 F00249 F00253 F00254 F00359 F00366 F00367 F00368 F00369 F00406 F00702 F00705 F00706 F01001 F01004 F02121 F02122 F02123 F02124 F02125 F02161 F02162 F02170 F02171 F02172 F02250 F02251 F02252 F02253 F12900 F12905 F43710 F43712 F43715 F43717 F43725 F43727 F43730 F43732 F43805 F43806 F43807 F43808 F62004 F62005 F62100 F62111 F88009 F88011 F88012 F88013 F88014 F88017 F88018 F88019 F88020 F88021 F88022 F88181 F88182 F88183
About this record

Access comprehensive regulatory information for SATELEC NEWTRON P5 XS / XS B.LED DENTAL ULTRASONIC CONSOLE in the Singapore medical device market through Pure Global AI's free database. This CLASS B medical device is registered under HSA registration number DE0509788 and owned by SATELEC, A company of ACTEONGROUP. The device was registered on September 17, 2024.

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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