Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3010595915

FEI Number

3010595915

Entity Name

NINGBO CASTLE MEDICAL IMPORT & EXPORT CO.,LTD

City/State/Country

Ningbo Zhejiang, CN

Establishment Address

Suite 1101, 88 Qianhe South Road, Yinzhou District, Ningbo Zhejiang 315100, CN

Establishment Type(s)

Manufacture Medical Device for Another Party (Contract Manufacturer)

Owner / Operator

NingBo Castle Medical Import & Export Co.,Ltd (Owner Number: 10045356)

Owner / Operator Contact Address

Suite 1101-1102, 88 Qianhe South Road, Yinzhou District, 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

SURGICAL CAP PATIENT POSITION SUPPORT Weekly Pill Pod Planner ICE BAG Surgical Light Handle Cover SKIN PRESSURE PROTECTOR ARM SLING GENERAL LABORATORY TIMER RECREATIONAL ADAPTOR Lens Paper,Bibulous Paper NON-MEASURING EXERCISER Drink holder NON-STERILE CRIMPER WIRE ENT HAND SPLINT AND COMPONENTS HYGIENE ADAPTOR ADHESIVE TAPE AND BANDAGE MEASURING TAPE RULERS AND CALIPERS Blade walking cane,cane Kidney stone collector EXTERNAL LIMB ANKLE/FOOT COMPONENT PERCUSSOR Urinary bag ESTHESIOMETER Gel Cushion TRANSFER AID Transfer board SUPPORT, BREATHING TUBE EXAMINATION AND TREATMENT CHAIR FILE CRUTCH AND WALKER CANE TIPS AND PADS EXAMINATION GOWN NONPOWERED DYNAMOMETER GENERAL SURGICAL SCISSORS OPERATING-ROOM SHOE COVER CAST SHOE CANNULA, NASAL, OXYGEN BATTERY POWERED MEDICAL EXAMINATION LIGHT PATIENT STAND-ON SCALE ARM SUPPORT Mini Massager PRIVACY SCREEN WHEELCHAIR ACCESSORIES PNEUMATIC TOURNIQUET WHEELCHAIR BELT Portable Medical Mini Nebulizer GENERAL & PLASTIC SURGERY MIRROR INFUSION STAND COVER & MATTRESS EXERCISE COMPONENTS MANUAL STETHOSCOPE LIMB BRACE ORTHOSIS CPAP Hose Holder SURGICAL APPAREL ACCESSORY Cervial traction

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
FYF	Cap, Surgical	General, Plastic Surgery	Class 1	878.4040	2013-11-08
CCX	Support, Patient Position	Anesthesiology	Class 1	868.6820	2013-11-08
NXB	Dispenser, Solid Medication	Physical Medicine	Class 1	890.5050	2016-12-19
KYR	Bag, Ice	General Hospital	Class 1	880.6050	2013-11-08
MDM	Instrument, Manual, Surgical, General Use	General, Plastic Surgery	Class 1	878.4800	2013-12-26
FMP	Protector, Skin Pressure	General Hospital	Class 1	880.6450	2013-11-08
ILI	Sling, Arm	Physical Medicine	Class 1	890.3640	2013-11-08
JBS	Timer, General Laboratory	Clinical Chemistry	Class 1	862.2050	2013-11-08
ILT	Adaptor, Recreational	Physical Medicine	Class 1	890.5050	2013-11-08
KHR	Absorber, Saliva, Paper	Dental	Class 1	872.6050	2019-08-15
ION	Exerciser, Non-Measuring	Physical Medicine	Class 1	890.5370	2013-11-08
IMZ	Holder, Crutch And Cane, Wheelchair	Physical Medicine	Class 1	890.3910	2019-04-29
NNN	Crimper, Wire, Ent, Non-Sterile	Ear, Nose, Throat	Class 1	874.3540	2013-11-08
ILH	Splint, Hand, And Components	Physical Medicine	Class 1	890.3475	2013-11-08
ILS	Adaptor, Hygiene	Physical Medicine	Class 1	890.5050	2013-11-08
KGX	Tape And Bandage, Adhesive	General Hospital	Class 1	880.5240	2013-11-08
FTY	Tape, Measuring, Rulers And Calipers	General, Plastic Surgery	Class 1	878.4800	2013-11-08
GFA	Blade, Saw, General & Plastic Surgery, Surgical	General, Plastic Surgery	Class 1	878.4820	2024-04-23
KHY	Cane, Safety Walk	Physical Medicine	Class 1	890.3075	2019-04-29
NNI	Container, Specimen, Non-Sterile	Pathology	Class 1	864.3250	2022-07-25
ISH	Component, External, Limb, Ankle/Foot	Physical Medicine	Class 1	890.3420	2013-11-08
GWZ	Percussor	Neurology	Class 1	882.1700	2013-11-08
FAQ	Bag, Urine Collection, Leg, For External Use, Sterile	Gastroenterology, Urology	Class 1	876.5250	2022-07-25
GXB	Esthesiometer	Neurology	Class 1	882.1500	2013-11-08
IMP	Cushion, Wheelchair	Physical Medicine	Class 1	890.3920	2019-04-29
IKX	Aid, Transfer	Physical Medicine	Class 1	890.5050	2013-11-08
JAY	Support, Breathing Tube	Anesthesiology	Class 1	868.5280	2023-04-09
FRK	Chair, Examination And Treatment	General Hospital	Class 1	880.6140	2013-11-08
HTP	File	Orthopedic	Class 1	888.4540	2013-11-08
INP	Tips And Pads, Cane, Crutch And Walker	Physical Medicine	Class 1	890.3790	2013-11-08
FME	Gown, Examination	General Hospital	Class 1	880.6265	2013-11-08
HRW	Dynamometer, Nonpowered	Orthopedic	Class 1	888.1250	2013-11-08
LRW	Scissors, General, Surgical	General, Plastic Surgery	Class 1	878.4800	2013-11-08
FXP	Cover, Shoe, Operating-Room	General, Plastic Surgery	Class 1	878.4040	2013-11-08
IPG	Shoe, Cast	Physical Medicine	Class 1	890.3025	2013-11-08
CAT	Cannula, Nasal, Oxygen	Anesthesiology	Class 1	868.5340	2023-04-09
KYT	Light, Examination, Medical, Battery Powered	General Hospital	Class 1	880.6350	2013-11-08
FRI	Scale, Stand-On, Patient	General Hospital	Class 1	880.2700	2013-11-08
IOY	Support, Arm	Physical Medicine	Class 1	890.3475	2013-11-08
ISA	Massager, Therapeutic, Electric	Physical Medicine	Class 1	890.5660	2025-05-21
FWZ	Operating Room Accessories Table Tray	General, Plastic Surgery	Class 1	878.4950	2013-11-08
KNO	Accessories, Wheelchair	Physical Medicine	Class 1	890.3910	2013-11-08
KCY	Tourniquet, Pneumatic	General, Plastic Surgery	Class 1	878.5910	2013-11-08
IQB	Belt, Wheelchair	Physical Medicine	Class 1	890.3920	2013-11-08
JPW	Pump, Nebulizer, Electrically Powered	Ear, Nose, Throat	Class 1	874.5220	2017-02-26
FTX	Mirror, General & Plastic Surgery	General, Plastic Surgery	Class 1	878.4800	2013-11-08
FOX	Stand, Infusion	General Hospital	Class 1	880.6990	2013-11-08
FMW	Cover, Mattress (Medical Purposes)	General Hospital	Class 1	880.6190	2013-11-08
IOD	Components, Exercise	Physical Medicine	Class 1	890.5350	2013-11-08
LDE	Stethoscope, Manual	Cardiovascular	Class 1	870.1875	2013-11-08
IQI	Orthosis, Limb Brace	Physical Medicine	Class 1	890.3475	2013-11-08
BYX	Tubing, Pressure And Accessories	Anesthesiology	Class 1	868.5860	2016-10-05
LYU	Accessory, Surgical Apparel	General, Plastic Surgery	Class 1	878.4040	2013-11-08
HST	Apparatus, Traction, Non-Powered	Orthopedic	Class 1	888.5850	2024-03-14

Official Correspondent

Tom Yang

US Agent Details

Jason Zhu Email: jzhu09@gmail.com Phone: (608) 5768559

Related Public Records

Same Entity

NingBo Castle Medical Import & Export 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
K944481	Garan Scientific, Inc.	THE HEART PROTECTOR	1995-04-10
K830425	Maddak, Inc.	TOILET SEAT RAISED	1983-05-09
K843874	Beiersdorf, Inc.	LEUKOPOR SURGICAL TAPE	1985-02-21
K915446	Sun Glitz Corp.	STRETCH WRAP	1992-05-06
K833120	Acme United Corp.	ONE TIME COMPOUND BENZOIN TINCTURE-	1983-12-29

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3010595915. Last updated year: 2026. Please use registration number 3010595915 when referencing this establishment in official correspondence.