TPH TECHNOLOGY MALAYSIA SDN. BHD.

FDA Device Registration & Listing · Rawang Selangor, MY · Registration 3031566471

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
3031566471
FEI Number
3031566471
Entity Name
TPH TECHNOLOGY MALAYSIA SDN. BHD.
City/State/Country
Rawang Selangor, MY
Establishment Address
NO 2 (BLOCK C), JALAN RAWANG INDAH 1, TAMAN INDUSTRI RAWANG,48000 Rawang, Selangor, Rawang Selangor 48000, MY
Establishment Type(s)
Manufacture Medical Device for Another Party (Contract Manufacturer)
Owner / Operator
TPH TECHNOLOGY MALAYSIA SDN. BHD. (Owner Number: 10090984)
Owner / Operator Contact Address
NO 2 (BLOCK C), JALAN RAWANG INDAH 1, TAMAN INDUSTRI RAWANG,48000 Rawang, Selangor, Rawang, MY-10 48000, MY
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
N/A
PMA Number
N/A

All Registered Proprietary Names

Nasal Aspirator, X1; Wearable Breast Pump, (Model S4DW); Thrive two-in-one Breast Pump TM, (Model P3); Wearable Breast Pump, (Model S1DW); Wearable Breast Pump, (Model P1); Wearable Breast Pump, (Model P3); Ameda GLO Wearable Breast Pump (Model W8S) Wearable Breast Pump (Model Comfort+) Ardo Melia Wearable Breast Pump (Model W8) ardo melia wearable breast pump (Model melia) breast shell insert Ameda GLO Wearable Breast Pump (Model W8S) Wearable Breast Pump (Model APEX10) Motif Aura Glow breast pump(Model Motif Aura Glow) Wearable Breast Pump(Model S33) Wearable Breast Pump(Model S12A) Wearable Breast Pump(Model W6) Wearable Breast Pump, (Model S15); Wearable Breast Pump, (Model bvk19up); Wearable Breast pump, (Model FS12B); Wearable Breast Pump (Model S12) kmaier,Wearable BreastPump (Model S12) MOMPINKE Wearable Breast Pump (Model S12) Jeeber, Wearable Breast Pump, (Model S12); Wearable Breast Pump, (Model S13); Wearable Breast Pump, (Model Abana); Lacevo Wearable Breast Pump (Model S70) Wearable Breast Pump, (Model S39); DiscreetDuo, Wearable Pump, (Model S32); Wearable Breast Pump (Model S36) MOMPINKE Wearable Breast Pump(Model S32) Wearable Breast Pump, (Model Bvk21); NICEGREEN LIFE WearableBreast Pump (Model S32) Wearable Breast Pump, (Model S32); Wearable Breast Pump, (Model S9); Wearable Breast Pump, (Model S10pro); Wearable Breast Pump, (Model S10); Wearable Breast Pump, (Model S19); Wearable Breast Pump, (YY-5030);

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
HGY Pump, Breast, Non-Powered Obstetrics/Gynecology Class 1 884.5150 2024-06-11
HGX Pump, Breast, Powered Obstetrics/Gynecology Class 2 884.5160 2024-06-13
HGX Pump, Breast, Powered Obstetrics/Gynecology Class 2 884.5160 2025-03-23
HGX Pump, Breast, Powered Obstetrics/Gynecology Class 2 884.5160 2025-02-24
HGX Pump, Breast, Powered Obstetrics/Gynecology Class 2 884.5160 2025-06-18
HGX Pump, Breast, Powered Obstetrics/Gynecology Class 2 884.5160 2025-09-11
HGX Pump, Breast, Powered Obstetrics/Gynecology Class 2 884.5160 2025-06-18
HGX Pump, Breast, Powered Obstetrics/Gynecology Class 2 884.5160 2025-09-11
HGX Pump, Breast, Powered Obstetrics/Gynecology Class 2 884.5160 2024-06-13
HGX Pump, Breast, Powered Obstetrics/Gynecology Class 2 884.5160 2025-06-18
HGX Pump, Breast, Powered Obstetrics/Gynecology Class 2 884.5160 2024-08-17
HGX Pump, Breast, Powered Obstetrics/Gynecology Class 2 884.5160 2024-06-13

Official Correspondent

No official correspondent registered.

US Agent Details

Thomas Tang Email: usagent@cefda.com Phone: (631) 7511103

Related Public Records

Same Entity

TPH TECHNOLOGY MALAYSIA SDN. BHD.
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
K190465 Hygeia II Medical Group, Inc. Evolve Breast Pump 2019-10-18
K021739 Limerick, Inc. LIMERICK POWERED ELECTRIC BREAST PUMP MODEL 1002 2003-01-10

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3031566471. Last updated year: 2026. Please use registration number 3031566471 when referencing this establishment in official correspondence.
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