Singapore HSA registration DE0510540
Siemens Atellica IM Anti‑Müllerian Hormone (AMH)
Singapore·CLASS B IVD·Siemens Healthcare Diagnostics Inc·Registered April 02, 2025Device classification
- Device Class
- CLASS B IVD
- Medical Speciality Area
- Immunology
Registration information
- Registration Number
- DE0510540
- Registration Date
- April 02, 2025
- Retention Due Date
- April 01, 2026
Product description
The Atellica® IM Anti‑Müllerian Hormone (AMH) assay is for in vitro diagnostic use in the quantitative determination of anti-Müllerian hormone (AMH) in human serum and plasma (lithium heparin) using the Atellica® Analyzer. The measurement of AMH, in conjunction with other clinical and laboratory findings, is used as an aid in the assessment of the ovarian reserve, and the prediction of poor ovarian response (≤ 4 oocytes retrieved) to controlled ovarian stimulation (COS).
Product Owner
- Short Name
- Siemens Healthcare
- Address
- 511 Benedict Avenue, Tarrytown, NY 10591-5097, UNITED STATES
Registrant
- Address
- 60 MACPHERSON ROAD, THE SIEMENS CENTRE, SINGAPORE 348615
Importer
- Address
- 60 MACPHERSON ROAD, THE SIEMENS CENTRE, SINGAPORE 348615
Model information
- Model Name(s)
- Atellica IM HCY DIL Atellica IM Anti‑Müllerian Hormone (AMH) Atellica IM AMH QC
- Model Identifier(s)
- 10995608 10998433 11205265
About this record
Access comprehensive regulatory information for Siemens Atellica IM Anti‑Müllerian Hormone (AMH) in the Singapore medical device market through Pure Global AI's free database. This CLASS B IVD medical device is registered under HSA registration number DE0510540 and owned by Siemens Healthcare Diagnostics Inc. The device was registered on April 02, 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.
Free DatabasePowered by Pure Global AIHSA Official DataCLASS B IVD