RACER TECHNOLOGY PTE LTD

FDA Device Registration & Listing · SINGAPORE South East, SG · Registration 9710609

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
9710609
FEI Number
3003202721
Entity Name
RACER TECHNOLOGY PTE LTD
City/State/Country
SINGAPORE South East, SG
Establishment Address
28 CHANGI SOUTH ST. 1, SINGAPORE South East 486772, SG
Establishment Type(s)
Manufacture Medical Device for Another Party (Contract Manufacturer)
Owner / Operator
RACER TECHNOLOGY PTE LTD (Owner Number: 9047394)
Owner / Operator Contact Address
No. 28, Changi South St. 1, Singapore, SG-NOTA 486772, SG
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
N/A
PMA Number
N/A

All Registered Proprietary Names

TympaHealth Gen 2 Otoscope Mypurmist 2 MyPurMist Mypurmist Free Smile Filter NTX150 Tonic Motor Activation (NTX150 TOMAC) System NTX100 Tonic Motor Activation (NTX100 TOMAC) System. Nidra Tonic Motor Activation (TOMAC) System

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
KSB Set, Transfer (Blood/Plasma) Hematology Class 2 864.9875 2022-08-03
KSB Set, Transfer (Blood/Plasma) Hematology Class 2 864.9875 2022-08-03
KSB Set, Transfer (Blood/Plasma) Hematology Class 2 864.9875 2022-08-03
ERA Otoscope Ear, Nose, Throat Class 1 874.4770 2020-10-19
KFZ Humidifier, Non-Direct Patient Interface (Home-Use) Anesthesiology Class 1 868.5460 2012-11-14
LCN Scraper, Tongue Dental Class 1 872.6855 2025-09-09
QWD Stimulator, Nerve, For Restless Legs Syndrome Neurology Class 2 882.5887 2025-06-16

Official Correspondent

No official correspondent registered.

US Agent Details

David Lennarz Business: REGISTRAR CORP Email: david.lennarz@registrarcorp.com Phone: (757) 2240177

Related Public Records

Same Entity

RACER TECHNOLOGY PTE LTD
View consolidated registration, premarket clearance, and recall records for this applicant.
View Entity Profile →

Related 510(k) Records

510(k) Number Applicant Device Name Decision Date
K932506 Rudolf Riester GmbH & Co. KG RI-SCOPE (S) 1993-10-08

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 9710609. Last updated year: 2026. Please use registration number 9710609 when referencing this establishment in official correspondence.
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