Pure Global

Siemens Atellica IM Anti‑Müllerian Hormone (AMH) - HSA Registration DE0510540

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 Database
Powered by Pure Global AI
HSA Official Data
CLASS B IVD
DE0510540
Siemens Atellica IM Anti‑Müllerian Hormone (AMH)
HSA Registration Number: DE0510540
Pure Global
DJ Fang

DJ Fang

MedTech Regulatory Expert

Need help with 30+ markets registration?

Pricing
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).

Device 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 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