# Guangdong Transtek Medical Electronics Co.,Ltd (contract manufacturer, Zhongshan Guangdong, CN): 4 new FDA device listings, incl. system, measurement, blood-pressure, non-invasive

**Score:** 80/100

| Field | Value |
|---|---|
| Establishment | Guangdong Transtek Medical Electronics Co.,Ltd |
| Role | Contract manufacturer |
| Establishment types | Manufacture Medical Device for Another Party (Contract Manufacturer); Export Device to the United States But Perform No Other Operation on Device; Manufacture Medical Device |
| Location | Zhongshan Guangdong, CN |
| New listings | 4 |
| Devices | System, Measurement, Blood-Pressure, Non-Invasive; Oximeter; Scale, Stand-On, Patient; Scale, Patient |
| Product codes | DXN, DQA, FRI, FRW |
| Device classes | Class I, Class II |
| Medical specialties | Cardiovascular, General Hospital |
| Brand names | Aktiia Init I1; Hilo Cuff; SMART BABY SCALE Model:0224 |
| First new listing | 2026-05-27 |
| Latest new listing | 2026-09-22 |
| FDA registration number | 3011420269 |
| Registration expires | 2027-12-31 |

## Why this score
- Contract manufacturer or sterilizer adding work.
- Class II or III devices: QMS and regulatory demands.
- Several new listings at once.
- Listed in the last 45 days.

Source: openFDA device registration and listing endpoint (U.S. Food and Drug Administration) (https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRL/rl.cfm). Last refreshed: 2026-11-04T21:52:36.524Z.
From the openFDA device registration and listing data, refreshed weekly. A listing shows a device an establishment says it makes or handles for the U.S. market; it is not FDA clearance or approval. Contact persons and street addresses are not stored. Verify in the FDA Establishment Registration and Device Listing database.