Singapore HSA registration DE0013436
MAQUET HLS Cannulae with BIOLINE Coating
Singapore·CLASS D·Maquet Cardiopulmonary GmbH·Registered July 24, 2013Device classification
- Device Class
- CLASS D
- Medical Speciality Area
- Cardiovascular
- HSA Product Code
- HSAMDD00110
- HS Code
- 90183910
Registration information
- Registration Number
- DE0013436
- Registration Date
- July 24, 2013
- Change Notification Approval Date
- October 28, 2024
- Retention Due Date
- July 23, 2025
Product description
The HLS Cannula is indicated for cannulation of all suitable vessels (e.g., femoral vessels) and forms the connection with the extracorporeal circulation. The cannula can be placed either by exposing the vessel or by means of the percutaneous Seldinger technique. Access for venous drainage is frequently via the femoral vein, jugular vein or subclavian vein (veno-arterial or veno-venous placement), and for arterial drainage, via the femoral artery (arterio-venous placement). Access for the arterial cannula is frequently via the femoral artery, subclavian artery or carotid artery (veno-arterial placement), or via the jugular vein, subclavian vein or femoral vein on the opposite side (veno-venous placement) and the femoral vein (arterio-venous placement). The decision on the application and the choice of venous and arterial access site is at the discretion of the surgeon and must be based on the anatomical conditions and the type of treatment planned. The maximum duration of use for the HLS Cannulae is 6 hours. The duration of use for the HLS Cannulae with BIOLINE COATING in combination with a PLS Set, ELS Set or HLS Set from MAQUET is up to 30 days.
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)
- Art. HLS Cannula OD = 15Fr (5.0 mm) Art. HLS Cannula OD = 17Fr (5.7 mm) Art. HLS Cannula OD = 19Fr (6.3 mm) Art. HLS Cannula OD = 21Fr (7.0 mm) Art. HLS Cannula OD = 23Fr (7.7 mm) Art. HLS Cannula OD = 15Fr (5.0 mm) Art. HLS Cannula OD = 17Fr (5.7 mm) Art. HLS Cannula OD = 19Fr (6.3 mm) Art. HLS Cannula OD = 21Fr (7.0 mm) Art. HLS Cannula OD = 23Fr (7.7 mm) Venous HLS Cannula OD = 21Fr (7.0 mm) Venous HLS Cannula OD = 23Fr (7.7 mm) Venous HLS Cannula OD = 25Fr (8.3 mm) Venous HLS Cannula OD = 29Fr (8.3 mm) Venous HLS Cannula OD = 19Fr (6.3 mm) Venous HLS Cannula OD = 21Fr (7.0 mm) Venous HLS Cannula OD = 23Fr (7.7 mm) Venous HLS Cannula OD = 25Fr (8.3 mm) Percutaneous Insertion Kit Percutaneous Insertion Kit Guide wire set PIK 100 cm Guide wire set PIK 150 cm
- Model Identifier(s)
- BE-PAL 1523 BE-PAL 1723 BE-PAL 1923 BE-PAL 2123 BE-PAL 2323 BE-PAS 1515 BE-PAS 1715 BE-PAS 1915 BE-PAS 2115 BE-PAS 2315 BE-PVL 2155 BE-PVL 2355 BE-PVL 2555 BE-PVL 2955 BE-PVS 1938 BE-PVS 2138 BE-PVS 2338 BE-PVS 2538 PIK 100 PIK 150 PIK Guide wire 100 PIK Guide wire 150
About this record
Access comprehensive regulatory information for MAQUET HLS Cannulae with BIOLINE Coating in the Singapore medical device market through Pure Global AI's free database. This CLASS D medical device is registered under HSA registration number DE0013436 and owned by Maquet Cardiopulmonary GmbH. The device was registered on July 24, 2013.
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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