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Maquet Blood Monitoring Unit BMU 40 - HSA Registration DE0007566

Access comprehensive regulatory information for Maquet Blood Monitoring Unit BMU 40 in the Singapore medical device market through Pure Global AI's free database. This CLASS C medical device is registered under HSA registration number DE0007566 and owned by Maquet Cardiopulmonary GmbH. The device was registered on September 20, 2011.

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
DE0007566
Maquet Blood Monitoring Unit BMU 40
HSA Registration Number: DE0007566
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Product Description

is intended to monitor blood parameters during cardiopulmonary bypass (CPB) or similar procedures with extracorporeal circulation, which require continuous monitoring of the arterial and/or venous blood parameters: partial pressure of oxygen (paO2), temperature (Ta and Tv), oxygen saturation (SvO2), hemoglobin (Hb) and hematocrit (Hct). Oxygen consumption (VO2) can also be calculated. Blood flow (QBlood) can be entered manually or values can be received from a connected heart-lung machine. The duration of application of the disposable products (arterial BMU Sensor and venous BMU Cell) is limited to six hours. The BMU 40 is designed for continuous operation.

Device Classification
Device Class
CLASS C
Medical Speciality Area
Cardiovascular
HSA Product Code
Refer to CRPNS
HS Code
90189030
Registration Information
Registration Number
DE0007566
Registration Date
September 20, 2011
Change Notification Approval Date
May 06, 2021
Retention Due Date
September 19, 2025
Product Owner
Short Name
Maquet Cardiopulmonary GmbH
Address
Kehler Str. 31, Rastatt, 76437, GERMANY
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)
Attachment to mast 33mm (Stockert and Terumo HLM) MAQUET BMU cell 1/2" MAQUET BMU cell 3/8" MAQUET BMU cell 1/4" MAQUET BMU Sensor 3/8" MAQUET BMU Sensor 1/4" MAQUET BMU Sensor 3/16" Blood Monitoring Unit BMU 40 Printer USB for BMU 40 Holder for BMU 40, 200 mm arm Holder for BMU 40, 100 mm arm Holder for BMU 40, 6 mm arm Transport case for BMU 40 Country Kit, BMU 40 Spare ink cartridge (black) Spare ink cartridge (red) Spare paper roll, 5 pcs per box Y-Datacable kit Attachment to slide rail 10 x 25 mm Mains power inlet cable (Power cord)
Model Identifier(s)
701033314 701040804 701040844 701040845 701040849 701040850 701040851 701040852 701043403 701043404 701043405 701043406 701043438 701045143 701045352 701045353 701045354 701045532 701046063 701047887