Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3006210673

FEI Number

3006210673

Entity Name

ZHEJIANG MEDIUNION HEALTHCARE GROUP CO.,LTD

City/State/Country

Ningbo Zhejiang, CN

Establishment Address

11-1, 167 Yening Street, Yinzhou District, Ningbo, China315000, Ningbo Zhejiang 315000, CN

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

ZHEJIANG MEDIUNION HEALTHCARE GROUP CO.,LTD (Owner Number: 9103599)

Owner / Operator Contact Address

31 YAOHANG ST, NINGBO, CN-ZJ 315000, CN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

EVERGRAND URINE BAG Face Mask,Stockinette,surgical drape URINE DRAINAGE SYSTEM skin stapler ,surgical skin stapler Evergrand specimen tube, Evergrand transport tube, and Evergrand collection tube DISPOSABLE HOT AND COLD PACK EVERGRAND ADMIT KIT EVERGRAND OXYGEN TUBE HOT AND COLD PACK Medicine Cup,Denture Cup ,Stool Container Denture Cup RETENTION; SURGICAL LOOP; SUTURE EVERGRAND LEG BAG plastic box Silicone Nipples pill box Dental hygiene kit EVERGRAND INSTRUMENT TRAY EVERGRAND SUCTION TUBE Gauze roll Disposable ice bag EVERGRAND SCRUB BRUSH,SPONGE STICK EVERGRAND SHOE COVER EVERGRAND TOWEL CLAMP EVERGRAND SCALPEL EVERGRAND MEASURING TAPE, EVERGRAND RULERS AND CALIPERS EVERGRAND BLOOD LANCETS EVERGRAND EAR SYRINGE Dental suction tip Thermometer, Clinical Mercury EVERGRAND CUFFED ENDOTRACHEAL TUBE Yankauer Suction Handle and Tube EVERGRAND ENDOTRACHEAL TUBE Nasopharyngeal Airway BEDPAN Wet wipes Flange for two pc pouch; one piece drainable pouch; one-pc closed pouch,Pouch Baby diaper ,Adult diaper ,Underpad bib holder EVERGRAND UMBILICAL CORD CLAMP bowl Peak flow meter Bite Blocks EVERGRAND LATEX GLOVES EVERGRAND synthetic GLOVES EVERGRAND VINYL GLOVES Latex examination glove EVERGRAND Nitrile GLOVES EVERGRAND PVC GLOVES Universal Examination Table, Nursing bed bibs, aprons, dental bib, paper bib, paper apron, plastic bib,exam paper roll Medline EVERGRAND VAGINAL SPECULUM Silicone tubing with connector (CPAP Adapter) triangular bandage Evergrand EVERGRAND BANDAGES AND TAPES,Probe cover,First Aid Plaster dental mirror COTTON BALL COTTON ROLL, DENTAL ROLL CPR MASK EVERGRAND OXYGEN MASK EVERGRAND DISPOSABLE SURGICAL INSTRUMENT EVERGRAND STETHOSCOPE EVERGRAND NASAL CANNULA plastic forceps Forceps EVERGRAND DISH 3 way stop-cocks Dental chair sleeves SKIN MARKER Scissors ,General EVERGRAND COTTON APPLICATOR Oral Swab Cotton Tips cotton buds Nasal swab Laryngeal Mask OROPHARYNGEAL AIRWAY ANESTHESIOLOGY Suspension Kit Evergrand Cinch Cover Evergrand Exam Gown Adjustable Metal Crutch, Cane, Walker, Rollator Safety Pins BV FILTER Anti Decubitus Cushion Safety Goggle,Glasses,face shield Evergrand Apron EVERGRAND BLADE SCALPEL Urine tube Test Tube Medical Transfer Pipettes;Inoculation Loops,Urine tube with screw lid BAG ,PLASTIC POUCH EVERGRAND FORCEPS Finger cot Plastic pipettes UNIT ORAL IRRIGATION DENTAL Exam table paper, disposable sheet roll medical paper sheet dental cup EVERGRAND SURGICAL CAPS MASKS GOWNS FACE MASK

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
EYZ	System, Urine Drainage, Closed, For Nonindwelling Catheter, Sterile	Gastroenterology, Urology	Class 1	876.5250	2007-06-27
LYU	Accessory, Surgical Apparel	General, Plastic Surgery	Class 1	878.4040	2012-05-24
NNZ	System, Urine Drainage, Closed, For Non-Indwelling Catheter, Non-Sterile	Gastroenterology, Urology	Class 1	876.5250	2022-07-13
GDT	Staple, Removable (Skin)	General, Plastic Surgery	Class 1	878.4760	2014-01-20
KDW	Container, Specimen Mailer And Storage, Temperature Controlled, Sterile	Pathology	Class 1	864.3250	2012-11-28
IMD	Pack, Hot Or Cold, Disposable	Physical Medicine	Class 1	890.5710	2012-04-03
NSB	Patient Personal Hygiene Kit	Dental	Class 1	872.6855	2007-06-27
BZB	Catheter, Nasal, Oxygen	Anesthesiology	Class 1	868.5350	2007-06-27
IME	Pack, Hot Or Cold, Reusable	Physical Medicine	Class 1	890.5700	2012-04-03
KDT	Container, Specimen Mailer And Storage, Sterile	Pathology	Class 1	864.3250	2012-10-22
KGS	Retention Device, Suture	General, Plastic Surgery	Class 1	878.4930	2016-02-18
FAQ	Bag, Urine Collection, Leg, For External Use, Sterile	Gastroenterology, Urology	Class 1	876.5250	2007-06-27
NXZ	Dental Hygiene Kit	Dental	Class 1	872.6855	2007-06-27
FSM	Tray, Surgical, Instrument	General, Plastic Surgery	Class 1	878.4800	2007-06-27
GCY	Apparatus, Suction, Single Patient Use, Portable, Nonpowered	General, Plastic Surgery	Class 1	878.4680	2007-06-27
NAB	Gauze / Sponge,Nonresorbable For External Use	General, Plastic Surgery	Class 1	878.4014	2007-06-27
KYR	Bag, Ice	General Hospital	Class 1	880.6050	2016-01-20
GEC	Brush, Scrub, Operating-Room	General, Plastic Surgery	Class 1	878.4800	2007-06-27
FXP	Cover, Shoe, Operating-Room	General, Plastic Surgery	Class 1	878.4040	2007-09-04
HXD	Clamp	General, Plastic Surgery	Class 1	878.4800	2007-06-27
GDX	Scalpel, One-Piece	General, Plastic Surgery	Class 1	878.4800	2007-06-27
FTY	Tape, Measuring, Rulers And Calipers	General, Plastic Surgery	Class 1	878.4800	2010-05-26
FMK	Single Use Only Blood Lancet With An Integral Sharps Injury Prevention Feature	General, Plastic Surgery	Class 2	878.4850	2007-06-27
KYZ	Syringe, Irrigating (Non Dental)	General Hospital	Class 1	880.6960	2007-06-27
EHZ	Evacuator, Oral Cavity	Dental	Class 1	872.6640	2016-03-16
FLK	Thermometer, Clinical Mercury	General Hospital	Class 2	880.2920	2020-06-17
BSR	Stylet, Tracheal Tube	Anesthesiology	Class 1	868.5790	2008-12-21
BTQ	Airway, Nasopharyngeal	Anesthesiology	Class 1	868.5100	2010-09-13
FOB	Bedpan	General Hospital	Class 1	880.6730	2015-08-05
LRJ	Disinfectant, Medical Devices	General Hospital	Class 1	880.6890	2007-12-10
EZS	Appliance, Colostomy, Disposable	Gastroenterology, Urology	Class 1	876.5900	2015-11-11
EYQ	Garment, Protective, For Incontinence	Gastroenterology, Urology	Class 1	876.5920	2015-03-25
LRP	Tray, Surgical	General, Plastic Surgery	Class 1	878.4800	2016-03-15
FOD	Device, Occlusion, Umbilical	General Hospital	Class 1	880.5950	2007-09-04
PHT	Basin For Endoscope Reprocessing	Gastroenterology, Urology	Class 1	876.1500	2022-08-05
KHA	Mask, Scavenging	Anesthesiology	Class 1	868.5590	2020-03-09
CAX	Flowmeter, Tube, Thorpe, Back-Pressure Compensated	Anesthesiology	Class 1	868.2340	2020-03-09
EGD	Wax, Dental, Intraoral	Dental	Class 1	872.6890	2016-03-16
IWP	Radiographic Protective Glove	Radiology	Class 1	892.6500	2008-06-26
LGX	Table, Examination, Medical, Powered	General, Plastic Surgery	Class 1	878.4960	2024-12-23
KHR	Absorber, Saliva, Paper	Dental	Class 1	872.6050	2014-09-11
FQL	Stocking, Medical Support (For General Medical Purposes)	General Hospital	Class 1	880.5780	2019-12-17
KOH	Instrument, Manual, General Obstetric-Gynecologic	Obstetrics/Gynecology	Class 1	884.4520	2009-05-31
CAI	Circuit, Breathing (W Connector, Adaptor, Y Piece)	Anesthesiology	Class 1	868.5240	2020-09-02
ILI	Sling, Arm	Physical Medicine	Class 1	890.3640	2016-01-11
NAE	Dressing, Wound, Hydrogel Without Drug And/Or Biologic	General, Plastic Surgery	Class 1	878.4022	2012-01-08
KGX	Tape And Bandage, Adhesive	General Hospital	Class 1	880.5240	2007-06-27
EAX	Mirror, Mouth	Dental	Class 1	872.4565	2016-01-26
FRL	Fiber, Medical, Absorbent	General Hospital	Class 1	880.5300	2010-06-22
BYG	Mask, Oxygen	Anesthesiology	Class 1	868.5580	2007-06-27
KDC	Instrument, Surgical, Disposable	General, Plastic Surgery	Class 1	878.4800	2010-05-26
LDE	Stethoscope, Manual	Cardiovascular	Class 1	870.1875	2007-06-27
CAT	Cannula, Nasal, Oxygen	Anesthesiology	Class 1	868.5340	2007-06-27
PUI	Drape, Surgical, Exempt	General, Plastic Surgery	Class 2	878.4370	2020-03-09
GEN	Forceps, General & Plastic Surgery	General, Plastic Surgery	Class 1	878.4800	2012-10-22
FNY	Basin, Emesis	General Hospital	Class 1	880.6730	2015-08-24
KIZ	Dish, Tissue Culture	Hematology	Class 1	864.2240	2007-06-27
DTL	Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass	Cardiovascular	Class 2	870.4290	2022-07-13
FRK	Chair, Examination And Treatment	General Hospital	Class 1	880.6140	2016-03-16
FZZ	Marker, Skin	General, Plastic Surgery	Class 1	878.4660	2022-07-13
LRW	Scissors, General, Surgical	General, Plastic Surgery	Class 1	878.4800	2016-03-24
KXF	Applicator, Absorbent Tipped, Non-Sterile	General Hospital	Class 1	880.6025	2007-06-27
CAE	Airway, Oropharyngeal, Anesthesiology	Anesthesiology	Class 1	868.5110	2007-06-27
KQZ	Component, Traction, Non-Invasive	Orthopedic	Class 1	888.5890	2012-05-24
KIA	Cover, Cast	General Hospital	Class 1	880.6185	2012-11-29
FME	Gown, Examination	General Hospital	Class 1	880.6265	2009-03-19
IMZ	Holder, Crutch And Cane, Wheelchair	Physical Medicine	Class 1	890.3910	2020-03-24
MDM	Instrument, Manual, Surgical, General Use	General, Plastic Surgery	Class 1	878.4800	2012-12-28
KRJ	Filter, Prebypass, Cardiopulmonary Bypass	Cardiovascular	Class 2	870.4280	2022-07-13
IMP	Cushion, Wheelchair	Physical Medicine	Class 1	890.3920	2020-03-24
HOY	Shield, Eye, Ophthalmic (Including Sunlamp Protective Eyewear And Post-Mydriatic Eyewear)	Ophthalmic	Class 1	886.4750	2015-12-21
IWO	Apron, Protective	Radiology	Class 1	892.6500	2007-12-06
GES	Blade, Scalpel	General, Plastic Surgery	Class 1	878.4800	2007-06-27
LXG	Equipment, Laboratory, General Purpose, Labeled Or Promoted For A Specific Medical Use	Clinical Chemistry	Class 1	862.2050	2012-12-04
KGY	Bag, Intestine	General, Plastic Surgery	Class 1	878.4100	2016-01-28
HTD	Forceps	General, Plastic Surgery	Class 1	878.4800	2007-06-27
LZB	Finger Cot	General Hospital	Class 1	880.6250	2022-04-05
JRC	Micro Pipette	Clinical Chemistry	Class 1	862.2050	2014-09-12
NRD	Unit, Operative Dental, Accessories	Dental	Class 1	872.6640	2016-03-16
KMN	Chair And Table, Medical	General Hospital	Class 1	880.6140	2012-12-26
EHK	Cup, Prophylaxis	Dental	Class 1	872.6290	2011-12-22
FYE	Dress, Surgical	General, Plastic Surgery	Class 1	878.4040	2007-06-27

Official Correspondent

Jason Sheen

US Agent Details

Siddiq Azeem Business: A&S International Email: siddiq@asint.biz Phone: (815) 2541110

Related Public Records

Same Entity

ZHEJIANG MEDIUNION HEALTHCARE GROUP 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
K913967	Doxtech, Inc.	DOX TAMPERPROOF SPECIMEN CONTAINER SYSTEM	1991-10-18
K880871	John Wagner Associates, Inc.	GRABBER WARM PACK/MINI MINI HEATER/FOOT HEATER	1988-05-20
K883982	Iberhospitex, S.A.	DRENOVAC	1989-02-23
K130132	Medipurpose Pte. , Ltd.	BABYLANCE HEEL INCISION DEVICE	2013-02-11
K881095	CooperVision, Inc.	KOI(TM) INSTRUMENT TRAYS	1988-04-06

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0505-2022	Philips North America Llc	1	Infa-Therm Transport Mattress, Reference Number 989805616831 1015
Z-0506-2022	Philips North America Llc	1	Infant Heel Warmers w/strap, Reference # 989805603201 1223
Z-0027-2016	Zimmer, Inc.	1	Zimmer Universal Locking System, Titanium 3.5mm. Zimmer Implant and Instrument Cases are reusable, non-implantable devices designed to facilitate organization, identification, storage, transportation, cleaning, and sterilization processing of reusable instruments and certain unused implantable devices.
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.

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3006210673. Last updated year: 2026. Please use registration number 3006210673 when referencing this establishment in official correspondence.