Singapore HSA registration DE0508073
Esaote Magnifico Open MR System
Device classification
- Device Class
- CLASS B
- Medical Speciality Area
- Radiology / Imaging
Registration information
- Registration Number
- DE0508073
- Registration Date
- May 05, 2023
- Retention Due Date
- May 04, 2026
Product description
Indications for use: Imaging portions of the upper limb, including the hand, wrist, forearm, elbow, arm and shoulder, imaging portions of the lower limb, including the foot, ankle, calf, knee, thigh, hip and pelvis, imaging the temporomandibular joint and imaging the cervical, the thoracic, the lumbar and the sacral sections as portions of the spinal column and imaging the head.
Product Owner
- Name
- Esaote S.p.A.
- Short Name
- Esaote S.p.A.
- Address
- 16152 Genova (GE) –Via Melen 77, ITALY
Registrant
- Name
- AUGXANO PTE LTD
- Address
- 60 PAYA LEBAR ROAD, PAYA LEBAR SQUARE, #05-08, SINGAPORE 409051
Model information
- Model Name(s)
- Magnifico Open Linear shoulder coil Knee coil Hand/wrist coil Foot/ankle coil MC shoulder coil Small L-spine coil Large L-spine coil Head Coil C-spine coil TMJ Coil
- Model Identifier(s)
- 100009900 130000018 130000019 130000020 130000021 130000022 130000023 130000024 130000025 130000026 130000027
About this record
Access comprehensive regulatory information for Esaote Magnifico Open MR System in the Singapore medical device market through Pure Global AI's free database. This CLASS B medical device is registered under HSA registration number DE0508073 and owned by Esaote S.p.A.. The device was registered on May 05, 2023.
This page provides complete registration details including product owner information, registrant details, 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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