Singapore HSA registration DE0509144
SEDECAL Radiographic System CHALLENGE X
Singapore·CLASS C·Sociedad Espanola de Electromedicina y Calidad, S.A. (SEDECAL)·Registered April 08, 2024Device classification
- Device Class
- CLASS C
- Medical Speciality Area
- Radiology / Imaging
Registration information
- Registration Number
- DE0509144
- Registration Date
- April 08, 2024
- Retention Due Date
- April 07, 2026
Product description
"This equipment is intended for use by qualified personnel only". The X-ray System Units are equipment included in a Medical Equipment System designed for general radiography in hospitals, clinics and medical practices to provide X-ray radiographic images of the skeleton, skull, chest, abdomen, extremities and other body parts. Images can be obtained with the patient in the sitting, standing or lying position. Examinations can be performed to any kind of patient group. Patients may be physically able, disable, immobilized or in a state of shock. The X-ray System contributes to the metrics of imaging performance ensuring the efficient use of radiation. The X-ray image receptors used in this system are Digital Detectors.”
Product Owner
- Short Name
- Sociedad Espanola de Electromedicina y Calidad, S.A. (SEDECAL)
- Address
- Poligono Industrial Rio de Janeiro, C/Pelaya, 9-13, 28110 ALGETE (Madrid), SPAIN
Registrant
- Address
- 211 HENDERSON ROAD, 211 HENDERSON, #08-02, SINGAPORE 159552
Importer
- Address
- 211 HENDERSON ROAD, 211 HENDERSON, #08-02, SINGAPORE 159552
Model information
- Model Name(s)
- Radiographic System CHALLENGE X: Ceiling Suspension CHALLENGEX Wall Stand CHALLENGEX Elevating Table NET500
- Model Identifier(s)
- CHALLENGEX AP CHAP CHWSAP NET500AP
About this record
Access comprehensive regulatory information for SEDECAL Radiographic System CHALLENGE X in the Singapore medical device market through Pure Global AI's free database. This CLASS C medical device is registered under HSA registration number DE0509144 and owned by Sociedad Espanola de Electromedicina y Calidad, S.A. (SEDECAL). The device was registered on April 08, 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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