Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3013152643

FEI Number

3013152643

Entity Name

CHANGZHOU MEIGUAN CARE PRODUCTS TECHNOLOGY CO.,LTD.

City/State/Country

Changzhou Jiangsu, CN

Establishment Address

Building #15, No.28, Industrial Road, Zouqu Town, Zhonglou Dist., Changzhou Jiangsu 213144, CN

Establishment Type(s)

Export Device to the United States But Perform No Other Operation on Device,Manufacture Medical Device

Owner / Operator

Changzhou Meiguan Care Products Technology Co.,LTD. (Owner Number: 10053563)

Owner / Operator Contact Address

Building #15, No.28, Industrial Road, Zouqu Town, Zhonglou Dist., Changzhou, CN-JS 213144, CN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Jockstrap Knee Guard Sterile Hypodermic Syringes for Single Use Sterile Eye Pad Waist Guard; Athletic Guard; Back Guard Daily Labor and Personal Protective Mask Lumbar Orthosis , Spine Support Medical External Fixation Splint Non-Sugical Isolation Gown Shoulder Pad Mask Filter Elbow Brace; Wrist Brace; Palm Guard Elastic Stocking NECK STRAP /HEAD STRAP/ULTRA STRAP Mouth Guard (Tooth protection) Head Guard; Neck Guard; Pediatric and Children Facemasks Sterile Gauze Sponges; Elbow Brace; Wrist Brace; Palm Guard; Ankle Support Mask Filters Antiviral and Antimicrobial Mask First Aid Kit Arm Guard Scavenging Mask Earflaps Guard Amniotic Fluid Sampler(amniocentesis tray) Leg Guard

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
FQJ	Support, Scrotal, Therapeutic	General Hospital	Class 1	880.5820	2016-12-22
ITQ	Joint, Knee, External Brace	Physical Medicine	Class 1	890.3475	2016-12-22
PGO	Anti-Stick Glass Syringe	Unknown	Class N	N/A	2016-12-16
HMP	Pad, Eye	General, Plastic Surgery	Class 1	878.4440	2016-12-22
IQJ	Splint, Clavicle	Physical Medicine	Class 1	890.3490	2016-12-22
QKR	Face Mask Within The Scope Of The Face Mask And Barrier Face Covering Enforcement Policy Or Face Mask Umbrella Eua	Unknown	Class N	N/A	2020-04-25
IQE	Orthosis, Lumbar	Physical Medicine	Class 1	890.3490	2019-04-04
FYH	Splint, Extremity, Noninflatable, External, Sterile	General, Plastic Surgery	Class 1	878.3910	2016-12-22
OEA	Non-Surgical Gown	General, Plastic Surgery	Class 1	878.4040	2020-02-18
IQQ	Joint, Shoulder, External Limb Component	Physical Medicine	Class 1	890.3420	2016-12-22
JRL	Unit, Filter, Membrane	Clinical Chemistry	Class 1	862.2050	2020-03-17
KFT	Assembly, Shoulder/Elbow/Forearm/Wrist/Hand, Mechanical	Physical Medicine	Class 1	890.3420	2016-12-22
FQL	Stocking, Medical Support (For General Medical Purposes)	General Hospital	Class 1	880.5780	2018-11-15
BTK	Strap, Head, Gas Mask	Anesthesiology	Class 1	868.5560	2018-04-02
KBN	Gag, Mouth	Ear, Nose, Throat	Class 1	874.4420	2016-12-22
NDA	Helmet, Cranial, For Protective Use	Physical Medicine	Class 1	890.3025	2016-12-22
OXZ	Pediatric/Child Facemask	General, Plastic Surgery	Class 2	878.4040	2020-04-03
KFX	Assembly, Thigh/Knee/Shank/Ankle/Foot, External	Physical Medicine	Class 2	890.3500	2016-12-16
KET	Filters, Cell Collection, Tissue Processing	Pathology	Class 1	864.3010	2020-03-17
OUK	Surgical Mask With Antimicrobial/Antiviral Agent	General, Plastic Surgery	Class 2	878.4040	2020-04-03
OHO	First Aid Kit Without Drug	General, Plastic Surgery	Class 1	878.4014	2016-12-16
IOY	Support, Arm	Physical Medicine	Class 1	890.3475	2016-12-22
KHA	Mask, Scavenging	Anesthesiology	Class 1	868.5590	2020-03-09
EWE	Protector, Hearing (Circumaural)	Unknown	Class U	N/A	2016-12-22
HIO	Sampler, Amniotic Fluid (Amniocentesis Tray)	Obstetrics/Gynecology	Class 1	884.1550	2020-11-09
OTX	Foot Wrap For Treating Restless Leg Syndrome Symptoms	Physical Medicine	Class 1	890.5760	2016-12-22

Official Correspondent

Jiang Hua

US Agent Details

Tony Zhang Business: Datatech inc. Email: tzhang@datatech-inc.com Phone: (610) 3536686

Related Public Records

Same Entity

Changzhou Meiguan Care Products 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
K812750	Instrumentation Laboratory CO	IL 703, STAT SEPARATOR	1982-01-26

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3013152643. Last updated year: 2026. Please use registration number 3013152643 when referencing this establishment in official correspondence.