Singapore HSA registration DE0503148
ICU Medical Swabcap
Device classification
- Device Class
- CLASS C
- Medical Speciality Area
- General Hospital
Registration information
- Registration Number
- DE0503148
- Registration Date
- May 27, 2019
- Change Notification Approval Date
- January 13, 2022
- Retention Due Date
- May 26, 2025
Product description
SwabCap is intended for use on swabable needlefree connectors as a cover to protect the needlefree connectors from potential contamination. The SwabCap acts as a physical barrier to contamination between line accesses and also serves as a disinfecting cleaner for use prior to line access. SwabCap will disinfect the connector five (5) minutes after application and maintains a disinfected connector surface for up to seven (7) days if not removed., Standalone Medical Mobile Application:
Product Owner
- Name
- ICU Medical Inc.
- Short Name
- ICU Medical Inc.
- Address
- 951 Calle Amanecer San Clemente, CA 92673, UNITED STATES
Registrant
- Address
- 65 UBI ROAD 1, OXLEY BIZHUB, #04-30, SINGAPORE 408729
Importer
- Address
- 65 UBI ROAD 1, OXLEY BIZHUB, #04-30, SINGAPORE 408729
Model information
- Model Name(s)
- SwabPackPlus™ Swabpack®, 10 Ct., Bag Swabpack®, 10 Ct., Bag Swabcap® Swabcap® Swabpack®, 25-ct. Bag Swabpack®, 25-ct. Bag
- Model Identifier(s)
- SCRC3-10-1600 SCXT3-10-2000 SCXT3-10-2000G SCXT3-2000 SCXT3-2000G SCXT3-2400 SCXT3-2400G
About this record
Access comprehensive regulatory information for ICU Medical Swabcap in the Singapore medical device market through Pure Global AI's free database. This CLASS C medical device is registered under HSA registration number DE0503148 and owned by ICU Medical Inc.. The device was registered on May 27, 2019.
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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