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MacroLux Medical Technology SeleneView® Single-Use Digital Hysteroscope - HSA Registration DE0510260

Access comprehensive regulatory information for MacroLux Medical Technology SeleneView® Single-Use Digital Hysteroscope in the Singapore medical device market through Pure Global AI's free database. This CLASS B medical device is registered under HSA registration number DE0510260 and owned by MacroLux Medical Technology Co., Ltd.. The device was registered on January 17, 2025.

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 B
DE0510260
MacroLux Medical Technology SeleneView® Single-Use Digital Hysteroscope
HSA Registration Number: DE0510260
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Product 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.

Device Classification
Device Class
CLASS B
Medical Speciality Area
Obstetrics & Gynaecology
Registration Information
Registration Number
DE0510260
Registration Date
January 17, 2025
Retention Due Date
January 16, 2026
Product Owner
Short Name
MacroLux Medical Technology Co., Ltd.
Address
301, Building 3, NamTai Inno Park In Guang Ming, Avenue, Guangming, 518107 Shenzhen, Shenzhen, CHINA
Registrant
Address
10 BUKIT BATOK CRESCENT, THE SPIRE, #07-01, SINGAPORE 658079
Importer
Address
10 BUKIT BATOK CRESCENT, THE SPIRE, #07-01, SINGAPORE 658079
Model Information
Model Name(s)
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(s)
HC29 HC29-G HC35 HC35-G HO35 HO35-G HO42 HO42-G