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CME BD Bodyguard™ Infusion Pump - HSA Registration DE0510191

Access comprehensive regulatory information for CME BD Bodyguard™ Infusion Pump in the Singapore medical device market through Pure Global AI's free database. This CLASS C medical device is registered under HSA registration number DE0510191 and owned by Caesarea Medical Electronics Ltd.. The device was registered on December 31, 2024.

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
DE0510191
CME BD Bodyguard™ Infusion Pump
HSA Registration Number: DE0510191
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Product Description

The BD BodyGuard™ infusion pump is designed for infusion of medications or fluids requiring continuous or intermittent delivery at precisely-controlled infusion rates through clinically acceptable routes of administration, including intravenous, subcutaneous, percutaneous, intra-arterial, epidural, intrathecal, in close proximity to nerves, and into an intraoperative site (soft tissue/body cavity/surgical wound site). The system is intended for patients who require maintenance medications, analgesics, PCA therapy, parenteral fluids, biosimilars, chemotherapeutic agents, blood or blood products infusion, and general fluids therapy in hospital and home care environments. The BD BodyGuard™ Pain Manager infusion pump is designed for patients who require epidural, Regional or PCA pain management. The BD BodyGuard™ Pain Manager infusion pump is for use by, or under the supervision of trained medical staff in the hospital and the home care environments.

Device Classification
Device Class
CLASS C
Medical Speciality Area
General Hospital
Registration Information
Registration Number
DE0510191
Registration Date
December 31, 2024
Retention Due Date
December 30, 2025
Product Owner
Short Name
Caesarea Medical Electronics Ltd.
Address
16 Shacham Street, Industrial Park, Caesarea North, PO Box 3009, Caesarea 3088900, ISRAEL
Registrant
Address
10 COLLYER QUAY, OCEAN FINANCIAL CENTRE, #10-01, SINGAPORE 049315
Importer
Address
10 COLLYER QUAY, OCEAN FINANCIAL CENTRE, #10-01, SINGAPORE 049315
Model Information
Model Name(s)
BD BodyGuard™ Infusion Pump BD BodyGuard™ Pain Manager Infusion Pump
Model Identifier(s)
999-603BDEN 999-803BDEN