FDA Registration
Active
🇲🇾 Malaysia
Wearable Breast Pump, (Model S21Pro);
Reg #: 3031566471
·
FEI: 3031566471
·
Expires 2025
Products
1
Proprietary Names
18
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- TPH TECHNOLOGY MALAYSIA SDN. BHD.
- Registration Number
- 3031566471
- FEI Number
- 3031566471
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- NO 2 (BLOCK C), JALAN RAWANG INDAH 1, TAMAN INDUSTRI RAWANG,48000 Rawang, Selangor
- City
- Rawang Selangor
- Country
- MY
Regulatory Submissions
- 510(k) Number
- K223886
Owner / Operator
- Firm Name
- TPH TECHNOLOGY MALAYSIA SDN. BHD.
- Operator Number
- 10090984
- Address
- NO 2 (BLOCK C), JALAN RAWANG INDAH 1, TAMAN INDUSTRI RAWANG,48000 Rawang, Selangor
- City
- Rawang
- State
- Selangor
- Postal Code
- 48000
- Country
- MY
- Correspondent
- Peter Chen
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Pump, Breast, Powered | HGX | Class 2 | Obstetrics/Gynecology | No | 2024-06-13 |
Proprietary Names
Wearable Breast Pump, (Model S21Pro);
Wearable Breast Pump, (Model S1);
MOMMED wearable breast pump (model S18 )
wearable breast pump (model S35)
Wearable Breast Pump, (Model E10);
Wearable Breast Pump, (Model W8S);
Wearable Breast Pump, (Model S18);
Wearable Breast Pump, (Model S22);
Wearable Breast Pump, (Model S70);
Wearable Breast Pump, (Model W8A);
Wearable Breast Pump, (Model W12);
Wearable Breast Pump, (Model S23);
Ameda GLO, Wearable Breast Pump, (Model W8S);
Wearable Breast Pump (Model W2)
Wearable Breast Pump, (Model S32);
Wearable Breast Pump, (Model melia);
Wearable Breast Pump, (Model S1 Pro);
Wearable Breast Pump, (Model S28);
Establishment Types
Repack or Relabel Medical Device