Vietnam MOH registration 240001707/PCBB-HN

IVD Department quantitative estradiol (E2) testing

VN: Bộ IVD xét nghiệm định lượng estradiol (E2)

Vietnam·Risk Class TTBYT Loại B·Theo theo phụ lục·Fujirebio Inc.·Registered Jul 15, 2024

Registration details

Analysis ID: 240001707/PCBB-HN
Submission ID: 000.00.19.H26-240613-0004
Product Type: Theo theo phụ lục
Product Code: Theo phụ lục

Company information

Manufacturer: Fujirebio Inc.
Manufacturer Country: Theo theo phụ lục
Product Owner: Fujirebio Inc.
Authorized Representative: CÔNG TY TNHH ARQON VIỆT NAM

Technical details

Intended Use: 1. Lumipulse G E2-III Immunoreaction Cartridges: For in vitro diagnostic use with LUMIPULSE G or serum. The E2 measurement can be used to assess ovarian function, monitor infertility treatment, and determine the time of ovulation in in vitro fertilization. This product is intended for professional use only. 2. Lumipulse G E2-III Calibrators: For in vitro diagnostic use in the calibration of the LUMIPULSE G System to quantify estradiol (E2) in serum or plasma. This product is intended for professional use only. 3. Lumipulse G Specimen Diluent 2: For in vitro diagnostic use: This product is a special reagent to dilute specimens in the Lumipulse G E2-III. This product is intended for professional use only.

Dates and status

Registration Date: Jul 15, 2024

About this record

Access comprehensive regulatory information for IVD Department quantitative estradiol (E2) testing in Vietnam's medical device market through Pure Global AI's free database. This Risk Class TTBYT Loại B medical device is registered under number 240001707/PCBB-HN and manufactured by Fujirebio Inc.. The authorized representative in Vietnam is CÔNG TY TNHH ARQON VIỆT NAM.

This page provides complete technical specifications, regulatory compliance details. Pure Global AI offers free access to 300,000+ Vietnamese medical device registrations, helping global MedTech companies navigate Vietnam MOH regulations, identify competitors, and discover partnership opportunities efficiently.