FDA Registration
Active
🇸🇬 Singapore
RACER TECHNOLOGY PTE LTD
Reg #: 9710609
·
FEI: 3003202721
·
Expires 2026
Products
6
Proprietary Names
8
Establishment Types
2
Classifications
6
Registration Details
- Registration Name
- RACER TECHNOLOGY PTE LTD
- Registration Number
- 9710609
- FEI Number
- 3003202721
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- 28 CHANGI SOUTH ST. 1
- City
- SINGAPORE South East
- Country
- SG
Owner / Operator
- Firm Name
- RACER TECHNOLOGY PTE LTD
- Operator Number
- 9047394
- Address
- No. 28, Changi South St. 1
- City
- Singapore
- State
- SG-NOTA
- Postal Code
- 486772
- Country
- SG
US Agent
- Business Name
- REGISTRAR CORP
- Contact Name
- David Lennarz
- Address
- 144 Research Drive
- City
- HAMPTON
- State
- VA
- ZIP
- 23666
- Country
- US
- [email protected]
- Phone
- 757 2240177
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Set, Transfer (Blood/Plasma) | KSB | Class 2 | Hematology | No | 2022-08-03 |
| Otoscope | ERA | Class 1 | Ear, Nose, Throat | No | 2020-10-19 |
| Humidifier, Non-Direct Patient Interface (Home-Use) | KFZ | Class 1 | Anesthesiology | No | 2012-11-14 |
| Scraper, Tongue | LCN | Class 1 | Dental | No | 2025-09-09 |
| Stimulator, Nerve, For Restless Legs Syndrome | QWD | Class 2 | Neurology | No | 2025-06-16 |
| Massager, Therapeutic, Electric | ISA | Class 1 | Physical Medicine | No | 2018-09-03 |
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
Establishment Types
Manufacture Medical Device for Another Party (Contract Manufacturer)
Manufacture Medical Device