Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3005031124

FEI Number

3005031124

Entity Name

Acute Ideas Co., Ltd.

City/State/Country

Taipei, TW

Establishment Address

3F, No.11, Lane 35, Jihu Road,, Taipei 114, TW

Establishment Type(s)

Repack or Relabel Medical Device,Manufacture Medical Device for Another Party (Contract Manufacturer)

Owner / Operator

Acute Ideas Co., Ltd. (Owner Number: 10023653)

Owner / Operator Contact Address

3F, No.11, Lane 35, Jihu Road,, Taipei, TW-TPE 114, TW

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

No proprietary names listed under this establishment.

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
FQL	Stocking, Medical Support (For General Medical Purposes)	General Hospital	Class 1	880.5780	2025-07-23
PWA	Breast Pump Accessory, Milk Expression Aid, Via Positive Pressure	Obstetrics/Gynecology	Class 1	884.5150	2024-11-25
HGX	Pump, Breast, Powered	Obstetrics/Gynecology	Class 2	884.5160	2020-05-10
EFW	Toothbrush, Manual	Dental	Class 1	872.6855	2009-06-08
GCY	Apparatus, Suction, Single Patient Use, Portable, Nonpowered	General, Plastic Surgery	Class 1	878.4680	2025-12-03
HGX	Pump, Breast, Powered	Obstetrics/Gynecology	Class 2	884.5160	2026-06-01
FLL	Continuous Measurement Thermometer	General Hospital	Class 2	880.2910	2020-04-11
HGX	Pump, Breast, Powered	Obstetrics/Gynecology	Class 2	884.5160	2013-01-04
HGY	Pump, Breast, Non-Powered	Obstetrics/Gynecology	Class 1	884.5150	2015-10-26
IQE	Orthosis, Lumbar	Physical Medicine	Class 1	890.3490	2025-07-23
KPD	Strip, Temperature, Forehead, Liquid Crystal	General Hospital	Class 2	880.2200	2011-11-16
KYX	Dispenser, Liquid Medication	General Hospital	Class 1	880.6430	2011-11-16
NTC	Nursing Pad, Hydrogel	General Hospital	Class 1	880.5630	2026-03-29

Official Correspondent

Albert Chen

US Agent Details

Jessica Wang Business: A Cute Baby, Inc. Email: matthew.kho@acutebaby.com Phone: (801) 6098168

Related Public Records

Same Entity

Acute Ideas 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
K190465	Hygeia II Medical Group, Inc.	Evolve Breast Pump	2019-10-18
K021739	Limerick, Inc.	LIMERICK POWERED ELECTRIC BREAST PUMP MODEL 1002	2003-01-10
K973236	Procter & Gamble Co.	CREST TOOTHBRUSH WITH MICROSHIELD	1998-03-11
K883982	Iberhospitex, S.A.	DRENOVAC	1989-02-23
K010462	Avita Corporation	AVITA PICCOLO/EXATO INFARED EAR THERMOMETER (TS2 & TS4 SERIES)	2001-04-11

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0020-04	Vital Concepts, Inc.	1	Huntington Instruments brand Irrigation Aspiration System with Single Spike Tubing and 33 cm Probe, Disposable (single use only), sterile, latex free. Catalog # 55040. Labeled as Manufactured for Huntington Instruments, Ogden Utah.
Z-0021-04	Vital Concepts, Inc.	1	Irrigation Aspiration System with Double Spike Tubing and 33 cm Probe, Disposable (single use only), sterile, latex free. Catalog # 55060. HYDRO-PRO brand labeled as sold by Vital Concepts, Inc., Grand Rapids, Michigan. Huntington Instruments brand labeled as Manufactured for Huntington Instruments, Ogden Utah. Quanta Technologies L.L.C. brand Manufactured for Quanta Technologies, L.L.C., Tucson, AZ. Catalogue # 55060-10 sold in Canada and labeled as Manufactured for Jac-Cell Medic, Dorval, Quebec.
Z-0022-04	Vital Concepts, Inc.	1	HYDRO-PRO brand Irrigation Aspiration System with double Spike Tubing, no Probe, Disposable (single use only), sterile, latex free. Catalog # 55160. Vital Concepts, Inc., Grand Rapids, Michigan.
Z-0023-04	Vital Concepts, Inc.	1	HYDRO-PRO brand Suction-Irrigation System without Probe, Disposable (single use only), sterile, latex free. R-Med Re-Order # 55170R; Distributed by R-Med, Inc., Orgeon, OH
Z-0024-04	Vital Concepts, Inc.	1	Quanta Technologies L.L.C. brand REORDER # LAPKIT 3. Contents 1 -55060 Suction/Irrigation Valve 2- 30012 Insufflation Tubing set 3- 5010 Anti Fog Solution with Sponge. Manufactured for Quanta Technologies, L.L.C., Tucson, AZ.

Similar Registrations

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3007576486	HERITAGE HOSIERY INC	Chattanooga, TN, US
3016932181	JIN MINNG INDUSTRIAL CO, LTD.	Shetou Township Changhua, TW
3010280404	YIWU QUINT HOSIERY CO., LTD	YIWU Zhejiang, CN

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3005031124. Last updated year: 2026. Please use registration number 3005031124 when referencing this establishment in official correspondence.