Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3008957229

FEI Number

3008957229

Entity Name

Airflo (Xiamen) Medical Co., Ltd.

City/State/Country

Xiamen Fujian, CN

Establishment Address

1F, 3F, 4F, No. 6, East Haijing Road, Haicang, Xiamen Fujian 361026, CN

Establishment Type(s)

Export Device to the United States But Perform No Other Operation on Device,Manufacture Medical Device

Owner / Operator

Grand Healthcare Co., Ltd. (Owner Number: 10026229)

Owner / Operator Contact Address

4F, No. 49, Section 2, Jen Ai Road, Taipei City, TW-TPE 100, TW

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

VacuSplint EZSplint Inflatable Cushion Effect Aries Taurus Air Flow Leo Scorpio Libra Airflo Air2Care 4, Air2Care 5, Air2Care 6, Air2Care 8, HybriMatt 100

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
NOC	Splint, Extremity, Non-Inflatable, External, Non-Sterile	General, Plastic Surgery	Class 1	878.3910	2009-11-25
KIC	Cushion, Flotation	Physical Medicine	Class 1	890.3175	2015-03-17
FNM	Mattress, Air Flotation, Alternating Pressure	General Hospital	Class 2	880.5550	2008-06-22

Official Correspondent

No official correspondent registered.

US Agent Details

Clare Ho Business: SHARE INFO INC. Email: cfrhealthcare@foxmail.com Phone: (929) 4102964

Related Public Records

Same Entity

Grand Healthcare Co., Ltd.

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

View Entity Profile →

Similar Registrations

Registration Number	Establishment Name	Location
3023346034	COMEBETTER (GUANGZHOU) TECHNOLOGY CO., LTD	Guangzhou Guangdong, CN
3029961128	GERO3D LTD	Tel Aviv-Yafo Central, IL
3043047582	OY PRIMO FINLAND AB	Vaasa Pohjanmaa, FI
3018759542	DIMENSION ORTHO Inc.	Philadelphia, PA, US
3009605026	JIANGSU SENOLO MEDICAL TECHNOLOGY CO., LTD.	Yancheng Jiangsu, CN

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3008957229. Last updated year: 2026. Please use registration number 3008957229 when referencing this establishment in official correspondence.