HSA · registration DE0510260MacroLux Medical Technology SeleneView® Single-Use Digital Hysteroscope
SingaporeObstetrics & GynaecologyClass BMacroLux Medical Technology Co., Ltd.
Official record identity
- Registration number
- DE0510260
- Model name
- SeleneView® Single-Use Digital Hysteroscope; SeleneView® Single-Use Digital Hysteroscope; SeleneView® Single-Use Digital Hysteroscope; SeleneView® Single-Use Digital Hysteroscope; SeleneView® Single-Use Digital Hysteroscope; SeleneView® Single-Use Digital Hysteroscope; SeleneView® Single-Use Digital Hysteroscope; SeleneView® Single-Use Digital Hysteroscope
- Model identifier
- HC29; HC29-G; HC35; HC35-G; HO35; HO35-G; HO42; HO42-G
- Registration date
- January 17, 2025
Classification
- Risk class
- Class B
Official value: CLASS B
Published parties
- Product owner
- MacroLux Medical Technology Co., Ltd.
- Registrant / registration holder
- RADIANCE MEDICAL SYSTEMS
Official description
The SeleneView® (model: HC29, HC29-G, HC35, HC35-G) is used to permit viewing of the cervical canal and uterine cavity for the purpose of performing diagnostic procedures. The SeleneView® (model: HO35, HO35-G, HO42, HO42-G) is used to permit viewing of the cervical canal and uterine cavity for the purpose of performing diagnostic and therapeutic procedures.
Additional source fields
- Product owner address
- 301, Building 3, NamTai Inno Park In Guang Ming, Avenue, Guangming, 518107 Shenzhen, Shenzhen, China
- Registrant address
- 10 BUKIT BATOK CRESCENT, #07-01, THE SPIRE, Singapore 658079
About this record
This page mirrors one row from HSA’s official registered-medical-device workbook. Product owner and registrant are separate published roles; neither is relabeled as the manufacturer. The official NOT_GENERATED value is retained when HSA does not publish a registration number, and the device name remains part of the stable record identity.