Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3006552462

FEI Number

3006552462

Entity Name

Ningbo Greatcare Medical Instruments Co., Ltd.

City/State/Country

NINGBO Zhejiang, CN

Establishment Address

No. 92 Cishanhe Rd., Chunxiao, Beilun, NINGBO Zhejiang 315830, CN

Establishment Type(s)

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

Owner / Operator

NINGBO GREATCARE TRADING CO., LTD. (Owner Number: 9102181)

Owner / Operator Contact Address

Unit 93, Building 12, No.818, Qiming Road, Yinzhou, NINGBO, CN-ZJ 315100, CN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Disposable PVC Laryngeal Mask Disposable Reinforced Silicone Laryngeal Mask Reusable Silicone Laryngeal Mask Reinforced and Reusable Silicone Laryngeal Mask Disposable Reinforced PVC Laryngeal Mask Disposable Silicone Laryngeal Mask Vomit Bag Needle Holder Suture Kit URINE DRAINAGE BAG LEMON GLYCERIN SWABSTICKS Enfit Syringe

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
CAE	Airway, Oropharyngeal, Anesthesiology	Anesthesiology	Class 1	868.5110	2015-08-10
FNY	Basin, Emesis	General Hospital	Class 1	880.6730	2015-10-31
HXK	Holder, Needle; Orthopedic	Orthopedic	Class 1	888.4540	2025-08-29
OVN	Suture Kit	General, Plastic Surgery	Class 2	878.4830	2025-08-29
KNX	Collector, Urine, (And Accessories) For Indwelling Catheter	Gastroenterology, Urology	Class 2	876.5250	2007-05-29
KOY	Degreaser, Skin, Surgical	General, Plastic Surgery	Class 1	878.4730	2010-03-18
KYZ	Syringe, Irrigating (Non Dental)	General Hospital	Class 1	880.6960	2016-04-06

Official Correspondent

No official correspondent registered.

US Agent Details

Charles Mack Business: IRC USA Email: ircfda@gmail.com Phone: (931) 6254938

Related Public Records

Same Entity

NINGBO GREATCARE TRADING 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
K791969	Medline Industries, Inc.	DYNACOR STERILE CLOSED SYS. DRAINAGE BAG	1979-11-05

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.

Similar Registrations

Registration Number	Establishment Name	Location
3037007211	ARETE MEDICAL DEVICES	Mullica Hill, NJ, US
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 3006552462. Last updated year: 2026. Please use registration number 3006552462 when referencing this establishment in official correspondence.