Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3008791328

FEI Number

3008791328

Entity Name

JIANGSU MCARE MEDICAL CO.,LTD.

City/State/Country

Danyang Jiangsu, CN

Establishment Address

No. 2 Qiandong Road, SiTu Town,, Danyang Jiangsu 212300, CN

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

Danyang Madicom Electromechanical Co., Ltd. (Owner Number: 10034964)

Owner / Operator Contact Address

No. 2 Qiandong Road, SiTu Town,, Danyang, CN-JS 212300, CN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

MDC-SUC MCARE MDC MDC RACK AND STAND OXYGEN REGULATOR MDK MDC MASK MDC-NASAL

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
GCY	Apparatus, Suction, Single Patient Use, Portable, Nonpowered	General, Plastic Surgery	Class 1	878.4680	2023-08-06
KFZ	Humidifier, Non-Direct Patient Interface (Home-Use)	Anesthesiology	Class 1	868.5460	2022-07-20
IKY	Mattress, Flotation Therapy, Non-Powered	General Hospital	Class 1	880.5150	2023-05-04
CCN	Flowmeter, Nonback-Pressure Compensated, Bourdon Gauge	Anesthesiology	Class 1	868.2300	2017-06-13
FOX	Stand, Infusion	General Hospital	Class 1	880.6990	2024-04-19
CAN	Regulator, Pressure, Gas Cylinder	Anesthesiology	Class 1	868.2700	2011-01-20
FNM	Mattress, Air Flotation, Alternating Pressure	General Hospital	Class 2	880.5550	2023-05-04
BYG	Mask, Oxygen	Anesthesiology	Class 1	868.5580	2023-06-17
CAT	Cannula, Nasal, Oxygen	Anesthesiology	Class 1	868.5340	2023-06-17

Official Correspondent

Gong AiZhen

US Agent Details

Fanny Zhao Business: J & F Technology Service Email: info@jf-yiliao.com Phone: (909) 5100201

Related Public Records

Same Entity

Danyang Madicom Electromechanical 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
K883982	Iberhospitex, S.A.	DRENOVAC	1989-02-23

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

Registration Number	Establishment Name	Location
3017101761	IC SURGICAL INC	Grand Rapids, MI, US
3010198939	TIANJIN VANFORM HIGH ENERGY PHYSICS TECHNOLOGY CO., LTD.	Tianjin, CN
3013025177	Phillips-Medisize Healthcare (Suzhou) CO., LTD	Suzhou Jiangsu, CN
1416980	BAXTER HEALTHCARE CORPORATION	ROUND LAKE, IL, US
3026986849	FANSHENG TECHNOLOGY (GUANGDONG) CO., LTD .	Zhongshan City Guangdong, CN

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3008791328. Last updated year: 2026. Please use registration number 3008791328 when referencing this establishment in official correspondence.