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Getinge 46-series Washer-Disinfector - HSA Registration DE0011962

Access comprehensive regulatory information for Getinge 46-series Washer-Disinfector in the Singapore medical device market through Pure Global AI's free database. This CLASS B medical device is registered under HSA registration number DE0011962 and owned by Getinge Disinfection AB. The device was registered on December 24, 2012.

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
DE0011962
Getinge 46-series Washer-Disinfector
HSA Registration Number: DE0011962
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Product Description

Intended for cleaning, disinfecting and drying surgical instruments (solid and tubular) and anesthesia equipment.

Device Classification
Device Class
CLASS B
Medical Speciality Area
General Hospital
HSA Product Code
HSAMDB00105
HS Code
84192000
Registration Information
Registration Number
DE0011962
Registration Date
December 24, 2012
Change Notification Approval Date
May 10, 2023
Retention Due Date
December 23, 2025
Product Owner
Short Name
Getinge Disinfection AB
Address
Ljungadalsgatan 11, 352 46 Vaxjo, SWEDEN
Registrant
Address
20 BENDEMEER ROAD, #06-01/02, SINGAPORE 339914
Importer
Address
20 BENDEMEER ROAD, CyberHub Building, #06-02, SINGAPORE 339914 20 BENDEMEER ROAD, #06-01/02, SINGAPORE 339914
Model Information
Model Name(s)
Spring Instrument holder Getinge 46-Series Getinge 46-Series Getinge 46-Series Getinge 46-Series Getinge 46-Series Getinge 46-Series Instrument tray, SPRI/ISO III Instrument tray, SPRI/ISO II Instrument tray, SPRI/ISO I Spring Test-tube basket Hose jet 8-16 mm SPRI/ISO II - close mesh lid Basket Basket Basket Mobile container for pipette cassettes Washing cassette for pipettes Drying cassette for pipettes Basket Injector pipe Injector pipe Injector pipe AN-cassette for 6 small catheters with 3โ€“10 mm bore. AN-cassette for 6 hoses for ISO-hoses with 22 mm bore. Lid for tray, SPRI/ISO I Lid for tray, SPRI/ISO II Stand for 1 canula, 5-10 mm Stand for 4 canulas, 5-10 mm Lid for tray, SPRI/ISO III AN-cassette for 6 hoses with 6โ€“25 mm bore. AN-cassette for 6 hoses with 25 mm bore. AN-cassette for 6 hoses with 6-25 mm bore. 6 loose injectors are included (498798000). Separate injector for 6 mm bore AN-cassette for 6 COAX/VIAXhoses with straight connection. Hose jet 12-21 mm Bird hose, bent Jet for angle connection Small instrument holder Small instrument holder Stand for kidney bowls Stand for bowls 211 mm Basket Injection pipe Stand for bowls 111 mm Stand for bowls 151 mm Instrument tray Drying cassette for pipettes Adjustable lid for basket Injector without holder Injector without holder Instrument tray for nasal specula Upper basic cart, single door model Basket Lower basic cart Lower basic cart AN-wash cart for hose cassettes Pipe injector head OP-wash cart, 4 levels / Lab-wash cart, 4 levels Transport trolley Transport trolley Transport trolley with drain and bottle Transport trolley with drain and bottle Holder for small hoses Injection bar Combination cart Lower injection cart for mixed goods Lower injection cart for large DURAN bottles Lower injection cart for large flasks Lower Injection cart for 1 laboratory cassette Bottle cassette DURAN bottles 100-1000 ml Upper injection cart for flasks 5-50 ml, half level Glass cassette for mixed laboratory glass Upper Injection cart for 1 laboratory cassette Cart for DIN-containers Pipette cart Upper injection cart for flasks 5-50 ml, full level Clamp injector head OP-wash cart, 3 levels / Lab-wash cart, 3 levels Storage table Basket Universal wash rack, U-shaped for tubular instruments Universal wash rack, L-shaped for tubular instruments Universal wash rack, U-shaped for tubular instruments Upper basic cart, pass-through model Upper injection cart for flasks 5-50 ml, full level AN-wash cart for integrated drying AN-spiral wash cart for integrated drying MIS-wash cart Universal wash rack, L-shaped for tubular instruments MIS instrument ramp Circular holder for small hoses Tourniquet holder Holder for 8 masks Universal wash rack, L-shaped for tubular instruments Injection pipe V-shaped Dental wash cart, 4 levels Universal wash rack, L-shaped Tray rack OP-wash cart, 4 levels Injector pipes for flasks 5-50 ml for injector carts Injector pipes with cut plastic profile for flasks 5-50 ml for injector carts Injector with one holder for flasks 5โ€“25 ml Injector with one holder and cut plastic profile for flasks 5โ€“25 ml Short injectors with longer holders Injector with three holders and cut plastic profile Long injectors with three holders Long injectors with three holders Luer jet female Luer jet female Luer jet male Luer jet male OP-wash cart, 5 levels Upper basic cart, single door model / Upper basic cart, pass-through model / Guide rails and spray arms for 46-4 Upper basic cart, single door model / Upper basic cart, pass-through model / Guide rails and spray arms for 46-5 Injection pipe V-shaped AN-spiral wash cart for integrated drying Injector pipes with three holders for injector carts MIS instrument ramp with luer lock and fine filter Injection pipe V-shaped Injection pipe V-shaped Double injection pipe V-shaped Double injection pipe V-shaped Double injection pipe V-shaped OP-wash cart, 2 levels / Lab-wash cart, 2 levels OP-wash cart, 4 levels Telescope basket Instrument holding system SPRI/ISO II - tight-mesh inner basket SPRI/ISO III - tight-mesh inner basket SPRI/ISO III - close mesh lid Instrument holding system
Model Identifier(s)
123618 400000401 46-2 46-3 46-4 46-4T 46-5 46-5T 466309101 466309201 466309301 468525000 468794400 468946600 476944000 477063300 477063301 477063302 477076100 477115500 477117400 477186600 477223201 477242500 477242600 477245500 477271100 477345200 477345300 477364900 498634400 498637400 498666600 498797800 498797801 498798000 498825200 498846100 498846400 498846600 498849900 498849901 498850200 498850300 498854300 498855900 498859600 498859700 498864100 498866500 498866800 498887003 498971200 499039300 499183100 499187900 499207600 499207601 499208100 499208400 499215800 499218800 499218801 499218802 499218803 499219100 499219200 499227800 499237100 499254800 499254801 499257400 499258400 499259900 499269000 499269100 499274000 499288100 499289500 499304200 499305100 499314400 499363700 499366600 499375300 499391200 499399300 499399400 499590500 499700700 499913200 500012000 500135300 500442000 500740800 500740900 500907900 500911500 500921200 501085500 501115400 501278500 501347900 501347901 501348000 501348001 501348100 501348101 501348300 501348400 501399400 501399401 501399500 501399501 501518100 501685901 501685904 501932500 501975600 502206300 502212201 502450200 502450201 502481100 502481101 502571800 502688000 502870700 561620802 561958501 932894 932895 932896 VDM411B