FDA Registration
Active
🇸🇬 Singapore
EVOCARE PTE. LTD.
Reg #: 3038613041
·
FEI: 3038613041
·
Expires 2026
Products
7
Proprietary Names
12
Establishment Types
1
Classifications
7
Registration Details
- Registration Name
- EVOCARE PTE. LTD.
- Registration Number
- 3038613041
- FEI Number
- 3038613041
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- 346C KING GEORGE'S AVENUE, KING GEORGE'S BUILDING
- City
- Singapore Central Singapore
- Country
- SG
Regulatory Submissions
- 510(k) Number
- K200159
Owner / Operator
- Firm Name
- EVOCARE PTE. LTD.
- Operator Number
- 10093428
- Address
- 346C KING GEORGE'S AVENUE, KING GEORGE'S BUILDING, SINGAPORE 208577
- City
- Singapore
- State
- SG-NOTA
- Postal Code
- 208577
- Country
- SG
- Correspondent
- Haiping Tan
US Agent
- Business Name
- ABMED SERVICE INC
- Contact Name
- Hui Hong
- Address
- 800 East Wishkah Street, 1021
- City
- Aberdeen
- State
- WA
- ZIP
- 98520
- Country
- US
- [email protected]
- Phone
- 303 8000162
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Continuous Measurement Thermometer | FLL | Class 2 | General Hospital | No | 2025-05-14 |
| Attachment, Commode, Wheelchair | INB | Class 1 | Physical Medicine | No | 2025-05-14 |
| Bottle, Collection, Vacuum | KDQ | Class 2 | General Hospital | No | 2025-06-09 |
| Pad, Menstrual, Unscented | HHD | Class 1 | Obstetrics/Gynecology | No | 2025-05-14 |
| Hearing Aid, Air-Conduction With Wireless Technology, Over The Counter | QUG | Class 2 | Ear, Nose, Throat | No | 2025-06-11 |
| Pack, Hot Or Cold, Disposable | IMD | Class 1 | Physical Medicine | No | 2025-05-14 |
| System, Measurement, Blood-Pressure, Non-Invasive | DXN | Class 2 | Cardiovascular | No | 2025-05-14 |
Proprietary Names
Infrared Body Thermometer,Model:H8831US
Upside Down Peri Bottle, Model: K5101US; Peri Bottle, Model: K5102US
No Touch Forehead Thermometer,Model:BNT100US
No Touch Forehead Thermometer,Model:BNT100US,VNT200US
Electric Nasal Aspirator,Model:HTD2601US, HTD2602US, H2603US, H2605US, H2606US, H2609AU, H2609US
Non-contact Infrared Body Thermometer,Model:HTD8808C,HTD8813C,HTD8818A,VNT275US
Non-contact Infrared Body Thermometer,Model:HTD8808C,HTD8813C,HTD8818A
Postpartum Catch-All Pads, Model: K5501US; Postpartum Pads, Model: K5502US
Infrared Body Thermometer,Model:HTD8220US
Behind-the-Ear Hearing Aid, model: HTD6102US
Instant Ice Maxi Pads, Postpartum Ice Pack Pads, Model: K5201US, K5202US
Electronic Blood Pressure Monitor,D6606US,D6607US
Establishment Types
Export Device to the United States But Perform No Other Operation on Device