Data / Medical devices / Malaysia / TPH Technology Malaysia Sdn. Bhd.
TPH Technology Malaysia Sdn. Bhd.: FDA-registered device maker in Johor Bahru, Malaysia, 19 510(k) clearances
TPH Technology Malaysia Sdn. Bhd. is registered with the FDA (registration 3031566471) in Johor Bahru, Malaysia. It lists 2 device types. The FDA files 19 510(k) clearances under its listings, the newest dated July 24, 2026. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3031566471
- Address
- Suite 18-01, Level 18, Menara Jland Johor Bahru City Centre, Jalan Tun Abdul Razak, 80888, Ibrahim International Business District, Johor, Malaysia, Johor Bahru, Malaysia, 80888
- Owner or operator
- TPH TECHNOLOGY MALAYSIA SDN. BHD. (10090984)
- Roles
- Repackager or relabeler
- First device listed
- June 11, 2024
- Registered through
- 2026
- Brand names listed
- Ameda GLO Wearable Breast Pump (Model W8S), Ameda GLO, Wearable Breast Pump, (Model W8S);, Ardo Melia Wearable Breast Pump (Model W8), DiscreetDuo, Wearable Pump, (Model S32);, DiscreetDuo Flow Wearable Breast Pump (Model S3), Jeeber, Wearable Breast Pump, (Model S12);, Lacevo Wearable Breast Pump (Model S70), MOMMED wearable breast pump (model S18 ) and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Pump, Breast, Non-Powered | HGY | 1 | Repackager or relabeler | accessdata.fda.gov |
| Pump, Breast, Powered | HGX | 2 | Repackager or relabeler | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| July 24, 2026 | K260259 | DiscreetDuo Flow Wearable Breast Pump (Model S3) | HGX | Substantially Equivalent | Shenzhen TPH Technology Co., Ltd. | accessdata.fda.gov |
| July 13, 2026 | K261199 | Wearable Breast Pump (Model S32A) | HGX | Substantially Equivalent | Shenzhen TPH Technology Co., Ltd. | accessdata.fda.gov |
| June 9, 2026 | K260864 | Mother's Nature W1 Warming Wearable Breast Pump | HGX | Substantially Equivalent | Shenzhen TPH Technology Co., Ltd. | accessdata.fda.gov |
| May 21, 2026 | K254244 | Wearable Breast Pump (Model S39) | HGX | Substantially Equivalent | Shenzhen TPH Technology Co., Ltd. | accessdata.fda.gov |
| September 8, 2025 | K251754 | Wearable Breast Pump (Model S33) | HGX | Substantially Equivalent | Shenzhen TPH Technology Co., Ltd. | accessdata.fda.gov |
| August 20, 2025 | K250383 | Wearable Breast Pump (Model W6) | HGX | Substantially Equivalent | Shenzhen TPH Technology Co., Ltd. | accessdata.fda.gov |
| July 15, 2025 | K250350 | Thrive 2-in-1 Breast Pump (Model P3) | HGX | Substantially Equivalent | Shenzhen TPH Technology Co., Ltd. | accessdata.fda.gov |
| May 30, 2025 | K250368 | Wearable Breast Pump (Model S21) | HGX | Substantially Equivalent | Shenzhen TPH Technology Co., Ltd. | accessdata.fda.gov |
| May 30, 2025 | K250365 | Motif Aura Glow breast pump (Model Motif Aura Glow) | HGX | Substantially Equivalent | Shenzhen TPH Technology Co., Ltd. | accessdata.fda.gov |
| April 21, 2025 | K243508 | Wearable breast pump (model S12A) | HGX | Substantially Equivalent | Shenzhen TPH Technology Co., Ltd. | accessdata.fda.gov |
| April 17, 2025 | K250829 | Lacevo Wearable Breast Pump (Model S70) | HGX | Substantially Equivalent | Shenzhen TPH Technology Co., Ltd. | accessdata.fda.gov |
| April 2, 2025 | K250152 | eufy Wearable Breast Pump S1 (T8D02) Model T8D02; eufy Wearable Breast Pump E10 (T8D03) Model T8D03; eufy Wearable Breast Pump S1 Pro (T8D04) Model T8D04; eufy Wearable Breast Pump E20 (T6060) Model T6060; | HGX | Substantially Equivalent | Shenzhen TPH Technology Co., Ltd. | accessdata.fda.gov |
| March 20, 2025 | K250463 | Ameda GLO Wearable Breast Pump (Model W8S) | HGX | Substantially Equivalent | Shenzhen TPH Technology Co., Ltd. | accessdata.fda.gov |
| February 21, 2025 | K242850 | Wearable breast pump (model W8) | HGX | Substantially Equivalent | Shenzhen TPH Technology Co., Ltd. | accessdata.fda.gov |
| July 1, 2024 | K240536 | Wearable Breast Pump (Model S32) | HGX | Substantially Equivalent | Shenzhen TPH Technology Co., Ltd. | accessdata.fda.gov |
| July 14, 2023 | K223886 | Wearable Breast Pump (Model S18) | HGX | Substantially Equivalent | Shenzhen TPH Technology Co., Ltd. | accessdata.fda.gov |
| January 4, 2023 | K222045 | Wearable Breast Pump (Model S1DW) | HGX | Substantially Equivalent | Shenzhen TPH Technology Co., Ltd. | accessdata.fda.gov |
| May 26, 2022 | K220596 | Wearable Breast Pump (Model S9) | HGX | Substantially Equivalent | Shenzhen TPH Technology Co., Ltd. | accessdata.fda.gov |
| February 11, 2022 | K212180 | Wearable Breast Pump (Model S12) | HGX | Substantially Equivalent | Shenzhen TPH Technology Co., Ltd. | accessdata.fda.gov |
Compare with other makers
Updated July 24, 2026. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.