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Melag MELAtherm 10 Evolution - HSA Registration DE0505553

Access comprehensive regulatory information for Melag MELAtherm 10 Evolution in the Singapore medical device market through Pure Global AI's free database. This CLASS C medical device is registered under HSA registration number DE0505553 and owned by MELAG Medizintechnik GmbH & Co. KG. The device was registered on March 10, 2021.

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 C
DE0505553
Melag MELAtherm 10 Evolution
HSA Registration Number: DE0505553
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Product Description

The MELAtherm 10 Evolution DTA/DTB is intended for use in a medical context such as a clinic or medical and dental practices. EN ISO 15883-1 and 2 defines it as a washer-disinfector intended for reprocessing medical instruments prior to their re-use or a further reprocessing step such as sterilization in a steam sterilizer.

Device Classification
Device Class
CLASS C
Medical Speciality Area
Dental
Registration Information
Registration Number
DE0505553
Registration Date
March 10, 2021
Retention Due Date
March 09, 2026
Product Owner
Short Name
MELAG Medizintechnik GmbH & Co. KG
Address
GeneststraรŸe 6-10, D-10829 Berlin, GERMANY
Registrant
Address
5 ANG MO KIO INDUSTRIAL PARK 2A, AMK TECH II, #05-21, SINGAPORE 567760
Importer
Address
5 ANG MO KIO INDUSTRIAL PARK 2A, AMK TECH II, #05-21, SINGAPORE 567760
Model Information
Model Name(s)
Instrument basket G Washing basket K Small-parts basket Insert rack for 3 MELAstore Instrument basket standard Sieve Cassette Tip support for instrument Basis basket without injector Protection inlay Penetration protection Separation inlay Instrument basket compact Clamp spring for injector Basket with injector rail Basket with injector rail MELAstore-Tray 50 MELAstore-Tray 100 MELAstore-Tray 200 MELAstore-Box 100 MELAstore-Box 200 Permanent filter for MELAstore Single-use paper filters Sub-cabinet for MELAtherm 10 Distance sleeve Holding frame Ceramic filter disc Stainless steel cover plate Adapter (female) for Luer Injector nozzle Adapter (male) for Luer Triple distributor Universal adapter Filter disc housing Adapter (male) for Luer-Lock Adapter for external spray channels Flex basket 1 Flex basket 2 Flex basket 3 Insert rack for 4 MELAstore Dirt filter of water supply Top frame for ear specula Top frame for ear specula Top frame for ear specula Top frame for ear specula Insert rack for impression trays, scissors and clamps Insert rack for hinged instruments Screw plug for injector rail Connector for hoses Connector for hoses Cover cap (male) for Luer-Lock Cover cap (female) for Luer Sieve cassette with separation Silicon hose 10/6mm Hose extension set with connections Double distributor Flex basket 6 Rinse sleeve for instruments Metal filter disc Instrument holder for flex baskets Flex basket specula Fixing clamp for top frame Top frame for nose specula Basket with injector rail Upgrade kit injector rail Central filter for injector Insert rack for 5 trays Adapter for ISO connector Adapter for Sirona Classic Adapter for heads of KaVo contra angles Adapter for W&H turbines Adapter for Sirona turbines Adapter for Kavo turbines Injector basket Flex 1 Adapter for tips Adapter for tips Adapter for tips Adapter for tips Adapter for tips Marking discs for adapters for tips Adapter for tips Insert rack for MELAstore MELAtherm 10 Evolution DTA MELAtherm 10 Evolution DTB
Model Identifier(s)
131 132 133 180 184 185 186 188 189 190 191 195 196 197 200 1180 1181 1182 1191 1192 1193 1194 11020 55120 62290 64375 65310 67250 73860 73880 73903 73904 73905 74130 74135 80010 80020 80030 80040 80050 80070 80080 80090 80100 80110 80120 80140 80150 80160 80170 80180 80185 80190 80195 80200 80255 80260 80350 80395 80410 80420 80435 80440 80480 80490 80590 80610 80620 80630 80640 80650 80660 80740 80750 80751 80752 80756 80760 80769 80790 80810 ME20020 ME20021