Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3006789357

FEI Number

3006789357

Entity Name

Anest Iwata Sparmax Co., Ltd.

City/State/Country

Dacun Changhua, TW

Establishment Address

No. 121, Sec. 3, Zhongshan Rd., Dacun Changhua 51542, TW

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

ANEST IWATA SPARMAX CO., LTD. (Owner Number: 10059043)

Owner / Operator Contact Address

4B-03 Taipei World Trade Center, 4F, No. 5, Sec. 5, Hsinyi Rd., Taipei, TW-TPE 11011, TW

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K080005

PMA Number

N/A

All Registered Proprietary Names

Suction Pump, AS-XXXX (family series) Cliq Aspirator DV-350 Cliq Aspirator, DV-300 CX-500 Compressor Cliq Aspirator, model DV-300 SPARMAX ASPIRATOR, MODELS TC-2000V ND VC-701

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
JCX	Apparatus, Suction, Ward Use, Portable, Ac-Powered	General, Plastic Surgery	Class 2	878.4780	2018-11-26
BTA	Pump, Portable, Aspiration (Manual Or Powered)	General, Plastic Surgery	Class 2	878.4780	2020-09-07
JCX	Apparatus, Suction, Ward Use, Portable, Ac-Powered	General, Plastic Surgery	Class 2	878.4780	2018-11-26
BTI	Compressor, Air, Portable	Anesthesiology	Class 2	868.6250	2020-07-01
JCX	Apparatus, Suction, Ward Use, Portable, Ac-Powered	General, Plastic Surgery	Class 2	878.4780	2018-11-26
JCX	Apparatus, Suction, Ward Use, Portable, Ac-Powered	General, Plastic Surgery	Class 2	878.4780	2018-11-26

Official Correspondent

No official correspondent registered.

US Agent Details

Amanda Singleton Email: amanda.compliance.sys.intl@gmail.com Phone: (716) 4407364

Related Public Records

Same Entity

ANEST IWATA SPARMAX 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
K082762	Aardvark Medical	AARDVARK NASAL IRRIGATION AND ASPIRATION DEVICE	2008-11-12
K900686	Medical Industries America, Inc.	MAXI COMPRESSORS	1990-04-26

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0038-05	Kinetic Concepts, Inc	2	V.A.C. X-Large Granufoam Dressing Part Numbers M6275065/5, V.A.C. ATS and V.A.C. Freedom and M6275043/5 V.A.C. Classic. Manufactured by Kinetic Concepts, Inc., San Antonio, Texas 78230
Z-0035-2007	Haemonetics Corporation	2	SmartSuction Harmony Powered Suction Device Model Number: HAR-E-115-US

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3006789357. Last updated year: 2026. Please use registration number 3006789357 when referencing this establishment in official correspondence.