Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3006395447

FEI Number

3006395447

Entity Name

ACARE TECHNOLOGY CO., LTD.

City/State/Country

New Taipei City, TW

Establishment Address

5F-4, No.24, Wuquan 2nd Rd, Xinzhuang District, New Taipei City 242, TW

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

ACARE TECHNOLOGY CO., LTD. (Owner Number: 9096601)

Owner / Operator Contact Address

5F-4, No.24, Wuquan 2nd Rd, Xinzhuang District, New Taipei City, TW-NOTA 242, TW

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Acare Spiracle VRV VACTUNE VARIOUS MOD VRA VRA-361 VRF FA-AM FA-AB FA-AT FA-OS FA-OM OXITUNE VARIOUS MODEL FLOWMETERS FA-TA FA-AD FA-OT FA-AS FA-OD FA-TD FA-OB Acare Suction Unit ASU-200 AC-SJ AC-ST9 (Safety Trap) AC-SJ-20 (Suction Bottle) AC-ST Acare AE-O2 Acare OxiSmarter I VSY VSC OXITUNE VARIOUS MODEL REGULATORS VST VSW VST-H01 Isolation gown Headgear Model RAG-100 Headgear Model RAG-200

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
CAE	Airway, Oropharyngeal, Anesthesiology	Anesthesiology	Class 1	868.5110	2013-07-29
KDP	Regulator, Vacuum	General Hospital	Class 2	880.6740	2007-08-29
CCN	Flowmeter, Nonback-Pressure Compensated, Bourdon Gauge	Anesthesiology	Class 1	868.2300	2023-02-17
JCX	Apparatus, Suction, Ward Use, Portable, Ac-Powered	General, Plastic Surgery	Class 2	878.4780	2019-11-12
KDQ	Bottle, Collection, Vacuum	General Hospital	Class 2	880.6740	2023-11-07
DQA	Oximeter	Cardiovascular	Class 2	870.2700	2010-11-19
DQA	Oximeter	Cardiovascular	Class 2	870.2700	2008-04-11
CAN	Regulator, Pressure, Gas Cylinder	Anesthesiology	Class 1	868.2700	2007-01-12
OEA	Non-Surgical Gown	General, Plastic Surgery	Class 1	878.4040	2020-06-12
BTK	Strap, Head, Gas Mask	Anesthesiology	Class 1	868.5560	2018-03-10

Official Correspondent

No official correspondent registered.

US Agent Details

Daniel Kamm Business: Kamm & Associates Email: fda.help.now@gmail.com Phone: (847) 3741727

Related Public Records

Same Entity

ACARE 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
K082762	Aardvark Medical	AARDVARK NASAL IRRIGATION AND ASPIRATION DEVICE	2008-11-12
K903523	Hewlett-Packard Co.	HP MODEL M1020A, ARTERIAL OXYGEN SAT/PLETH MODULE	1990-10-23
K973147	Nellcor Puritan Bennett, Inc.	NPB-295 PULSE OXIMETER	1997-11-14
K231243	Guangdong Genial Technology Co., Ltd.	Finger Clip Pulse Oximeter	2023-10-31
K971628	Somanetics Corp.	SOMANETICS INVOS 3100A CEREBRAL OXIMETER (INVOS)	1997-10-10

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0002-2014	King Systems Corp.	1	King LTS-D Oropharyngeal Airways Product Usage: The King LTS-D is intended for use in adult patients (in excess of 25 kg) for controlled ventilation during anesthesia for procedures that are short in duration and when the patient is considered to have a low risk of aspiration of stomach contents.
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-0020-2019	Oridion Medical 1987 Ltd. Har Hotzvim Industrial	2	CAPNOSTREAM 20 (US) N, Part Number CS08651
Z-0022-2019	Oridion Medical 1987 Ltd. Har Hotzvim Industrial	2	CAPNOSTREAM 20P (US) N - ROHS, Part Number CS08651-02
Z-0023-2019	Oridion Medical 1987 Ltd. Har Hotzvim Industrial	2	CAPNOSTREAM 20P (US) N - ROHS, Part Number CS08651-03

Similar Registrations

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3012508471	P3 MEDICAL LTD	Bristol Bristol, City of, GB
3014829416	MCMURRAY MEDICAL	Minneapolis, MN, US
3015314035	Bio-Med Healthcare Products Pvt. Ltd.	Palwal Haryana, IN
3008281139	DANYANG XINYA VALVE CO., LTD.	Danyang Jiangsu, CN

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3006395447. Last updated year: 2026. Please use registration number 3006395447 when referencing this establishment in official correspondence.