Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3020638914

FEI Number

3020638914

Entity Name

SHENZHEN IVANKACA TECHNOLOGY CO.,LTD

City/State/Country

shenzhen Guangdong, CN

Establishment Address

floor 3, building C3, hongdehui Industrial Zone, No. 128, Kangqiao Road, Nanwan street, Longgang District, shenzhen Guangdong 518114, CN

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

Shenzhen Ivankaca Technology Co.,Ltd (Owner Number: 10082876)

Owner / Operator Contact Address

floor 3, building C3, hongdehui Industrial Zone, No. 128, Kangqiao Road, Nanwan street, Longgang District, shenzhen, CN-GD 518114, CN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K201397

PMA Number

N/A

All Registered Proprietary Names

Ultrasonic Mesh nebulizer MY-123 MY-135B MY-136B MY-126 MY-132B MY-130 MY-125

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
CAF	Nebulizer (Direct Patient Interface)	Anesthesiology	Class 2	868.5630	2021-10-10

Official Correspondent

YanShen Huang

US Agent Details

Anny zhao Business: Hlongmed International Ltd. Email: usagent@hlongmed.com Phone: (503) 3344880

Related Public Records

Same Entity

Shenzhen Ivankaca Technology Co.,Ltd

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
K163485	Adherium (Nz), Ltd.	SmartTouch	2017-08-30
K781467	Travenol Laboratories, S.A.	U-FLOAT VALVE 2D9023	1978-09-07

Similar Registrations

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1110315	MYLAN PHARMACEUTICALS INC.	Morgantown, WV, US
3018783526	CEVA LOGISTICS NETHERLANDS BV (Venray)	Oostrum Limburgh, NL
3005998497	SUNMED AP, LTD.	ZHUHAI Guangdong, CN
3006852037	Omron Healthcare Manufacturing Vietnam Co., Ltd.	Ho Chi Minh City, VN
3006783791	GaleMed (Xiamen) Co., Ltd.	XIAMEN Fujian, CN

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3020638914. Last updated year: 2026. Please use registration number 3020638914 when referencing this establishment in official correspondence.