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Singapore HSA registration DE0010763

Reichert Unistat Bilirubinometer

Singapore flagSingapore·CLASS B IVD·Reichert Inc.·Registered September 12, 2012
Device classification
Device Class
CLASS B IVD
Medical Speciality Area
Immunology
HSA Product Code
Refer to HPR, CWC, LCS, PHU, BSB
HS Code
30029000
Registration information
Registration Number
DE0010763
Registration Date
September 12, 2012
Change Notification Approval Date
October 02, 2024
Retention Due Date
September 11, 2025
Product description
Bilirubin (total and unbound) in the neonate test system is a device intended to measure the level of Bilirubin (total and unbound) in the blood (serum) of newborn infants to aid in indicating the risk of bilirubin encephalopathy (kernicterus)
Product Owner
Name
Reichert Inc.
Short Name
Reichert
Address
3362 Walden Avenue, Depew, NY 14043, UNITED STATES
Registrant
Name
EMERGO SINGAPORE CONSULTING PRIVATE LIMITED
Address
1 HARBOURFRONT PLACE, HARBOURFRONT TOWER ONE, #11-01-03, SINGAPORE 098633
Importer
Name
LEICA MICROSYSTEMS (SEA) PTE LTD
Address
15 TUKANG INNOVATION DRIVE, SINGAPORE 618299
Model information
Model Name(s)
Box of 51 disposable cuvettes Reichert Unistat Bilirubinometer (115VAC) Reichert Unistat Bilirubinometer (230VAC) Calibration cuvette High Level Check cuvette Package of three replacement bulbs
Model Identifier(s)
13102140 1310310C 1310311C 13103410 13103420 13110630
About this record

Access comprehensive regulatory information for Reichert Unistat Bilirubinometer 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 DE0010763 and owned by Reichert Inc.. The device was registered on September 12, 2012.

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