Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3033773618

FEI Number

3033773618

Entity Name

ORTUS MEDI-TECH CO., LTD.

City/State/Country

Shenzhen City Guangdong, CN

Establishment Address

203, Building C4, Tong Fu Yu lndustrial Park, FuPing Road, Ping Di, Longgang, Shenzhen City Guangdong 518117, CN

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

Ortus Medi-Tech Co., Ltd. (Owner Number: 10091777)

Owner / Operator Contact Address

203, Building C4, Tong Fu Yu lndustrial Park, FuPing Road, Ping Di, Longgang, Shenzhen City, CN-GD 518117, CN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Ortus, Disposable Inflation Device, OM-ID-0120, OM-ID-0220, OM-ID-0320, OM-ID-0420 Ortus, Disposable Pressure Bandage, OM-TB02, OM-TB03

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
PTM	Syringe, Balloon Inflation, Exempt	Cardiovascular	Class 2	870.1650	2024-10-31
KCY	Tourniquet, Pneumatic	General, Plastic Surgery	Class 1	878.5910	2024-10-31

Official Correspondent

Panpan Hu

US Agent Details

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

Related Public Records

Same Entity

Ortus Medi-Tech Co., Ltd.

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3033773618. Last updated year: 2026. Please use registration number 3033773618 when referencing this establishment in official correspondence.