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Terviseamet
FOR VISUALLY IMPAIRED

Medical device

MSA code 16553
Basic UDI-DI
Seadme klass Meditsiiniseade
Medical Device Nomenclature
Risk class I sterile
Appliance -
Device name (in Estonian) Qufora® voodi kott, 2000ml, 120cm voolik, kokkupandav kangkraan, SPC; Qufora® voodi kott, 2000ml, 120cm voolik, kokkupandav T-kraani väljalaskeava, SPC
Device name (in English) Qufora® Bed Bag, 2000ml, 120cm tube, fold-away lever tap, SPC; Qufora® Bed Bag, 2000ml, 120cm tube, fold-away T-tap outlet, SPC
Intended use (is Estonian) Steriilne Qufora® tühjendatav, voodi külge kinnitatav, nõelavaba analüüsivõtukohaga ja integreeritud õhufiltriga uriinikott ühendatakse kuseteede kateeri külge.
Intended use (in English) The sterile Qufora® drainable bed bags with a needle-free sample port and integrated ventilation filter can be attached to either a urinary catheter.
Type/model/article number 14823202; 14853202
Notified body 0123
Manufacturer Changshu Zengfu Mediacal Device Co., Ltd
Authorised representative Shanghai International Holding Corp. GmbH (Europe)
In register from 05/04/2021
Entry status Active
Pakendiinfo
Reimbursed by EHIF +
Documents related to medical device model
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