Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3016758972

FEI Number

3016758972

Entity Name

ANJI SPENQ INDUSTRIAL CO., LTD.

City/State/Country

Huzhou Zhejiang, CN

Establishment Address

F16,Building C, Anji Chamber of Commerce Mansion, No.99 Tianhuangping South Road, Anji County, Huzhou Zhejiang 313300, CN

Establishment Type(s)

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

Owner / Operator

ANJI SPENQ INDUSTRIAL CO., LTD. (Owner Number: 10085700)

Owner / Operator Contact Address

F16,Building C, Anji Chamber of Commerce Mansion, No.99 Tianhuangping South Road, Anji County, Huzhou, CN-ZJ 313300, CN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Device, Urine Flowrate Measuring, Non-Electrical, Disposable Gauze Swabs With X-Ray,Gauze Balls With X-Ray, Gauze Bandage With X-Ray,Gauze Roll With X-Ray; Gauze Zig-Zag With X-Ray,Gauze Cutting With X-Ray,Lap Sponges With X-Ray RESTRAINT, WHEELCHAIR, NON-PROTECTIVE ORTHOSIS, LUMBO-SACRAL Suction Catheter,TRACHEOBRONCHIAL Tube Wound Dressing, Wound Plaster, IV DRESSING Syringe, Irrigation Sanitary Napkin SPECIMEN CONTAINER, URINE CONTAINER, STOOL CONTAINER CERVICAL-THORACIC; FOAM COLLAR; PLASTIC COLLAR; RIGID Disposable Goggles, Face Guard, Face Shield TUBE, ASPIRATING, FLEXIBLE, CONNECTING,Yankauer Handle Alcohol Prep Pad,Alcohol Swabs, Povidone-Iodine Pad,BZK Antiseptic Pad, Antiseptic Cleaning Wipe Tongue Depressor TOURNIQUET Test Tube ORTHOSIS, LIMB BRACE Adhesive Tape, Elastic Adhesive Bandage, Cohesive Bandage, Kinesiology Tape, Silicone Tape Cotton -Tipped Applicator, Cotton Swabs, Cottton Buds SKIN CLOSURE Mixer, Blood Mixer ID Bracelet; Identification Band Nebulizer Mask, Simple Oxygen Mask SUPPORT, ARM EYE PAD Container, Specimen, Sterile Skin Protective Paste; Skin Protective Powder Anti-Leakage Strip; Hydrocolloid Skin Barrier; Hydrocolloid Skin Protective Ring;; Protective Dressing Wipe; 3-Ply Face Mask; Disposable Surgical Mask; KN95 Mask; Non-Woven Face Mask Orthosis, Cervical Colostomy Bag,Colostomy Pouch,Urostomy Bag Absorbent Cotton Roll, Zig-Zag Cotton Wool, Cotton Pad, Cotton Ball Orthopedic Casting Tape, Orthopedic Splint Tweezers,Forceps Slides,Microscope SPLINT, HAND, AND COMPONENTS HYDROCOLLOID FOAM DRESSING; HYDROGEL DRESSING Cold Pack,Hot Pack,Hot/Cold Pack,Cooling Gel Patch SUCTION YANKAUER, SUCTION CATHETER JOINT, KNEE, EXTERNAL BRACE Dish, Tissue Culture CENTRIFUGE Bedpan Triangular Bandage,Arm Sling Oxygen Mask,Non-Rebrething Mask PE Apron, CPE Apron, PVC Apron, Non-Woven Apron Silicone Dressing,Silicone Scar Sheet ORTHOSIS, LUMBAR Foam Dressing; Hydrocolloid Dressing; Hydrocolloid Foam Dressing; Nonwoven Wound Dressing; Silicone Dressing; Super Absorbency Dressing; Ultra Thin Absorbent Film First Aid Bag, First Aid Kit; Instrument Cases/First Aid Case/Plastic Case STOCKING, MEDICAL SUPPORT Alginate Dressing,FOAM DRESSING Set,Hydrophilic Dressing Bedsheet, Bed Cover,BODY BAG, Emergency Blanket Gauze Swabs,Gauze Balls,Gauze Bandage,Gauze Roll,Gauze Zig-Zag, Gauze Cutting, Lap Sponges VAGINAL SPECULUM Laryngeal Mask Airway,Guedel Airway,Nasal Airway Isolation Gown, Lab Coat, Coverall, PE Gown BAG, URINE COLLECTION, LEG, FOR EXTERNAL USE, STERILE Plaster Of Paris Bandage, Undercast Padding Urinal

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
FFG	Device, Urine Flow Rate Measuring, Non-Electrical, Disposable	Gastroenterology, Urology	Class 2	876.1800	2022-07-23
GDY	Gauze/Sponge, Internal, X-Ray Detectable	General, Plastic Surgery	Class 1	878.4450	2022-07-23
KID	Restraint, Wheelchair, Non-Protective	Physical Medicine	Class 1	890.3910	2022-07-23
IPY	Orthosis, Lumbo-Sacral	Physical Medicine	Class 1	890.3490	2022-07-23
BSY	Catheters, Suction, Tracheobronchial	Anesthesiology	Class 1	868.6810	2022-07-23
MCY	Wound Dressing Kit	General Hospital	Class 2	880.5075	2022-07-23
KYZ	Syringe, Irrigating (Non Dental)	General Hospital	Class 1	880.6960	2022-07-23
HHD	Pad, Menstrual, Unscented	Obstetrics/Gynecology	Class 1	884.5435	2022-07-23
NNI	Container, Specimen, Non-Sterile	Pathology	Class 1	864.3250	2022-07-23
IQF	Orthosis, Cervical-Thoracic, Rigid	Physical Medicine	Class 1	890.3490	2022-07-23
HOY	Shield, Eye, Ophthalmic (Including Sunlamp Protective Eyewear And Post-Mydriatic Eyewear)	Ophthalmic	Class 1	886.4750	2022-07-23
BYY	Tube, Aspirating, Flexible, Connecting	General Hospital	Class 2	880.6740	2022-07-23
LRJ	Disinfectant, Medical Devices	General Hospital	Class 1	880.6890	2022-07-23
FMA	Depressor, Tongue, Non-Surgical	General Hospital	Class 1	880.6230	2022-07-23
GAX	Tourniquet, Nonpneumatic	General, Plastic Surgery	Class 1	878.5900	2022-07-23
KJG	Tube, Tissue Culture	Pathology	Class 1	864.3010	2022-07-23
IQI	Orthosis, Limb Brace	Physical Medicine	Class 1	890.3475	2022-07-23
KGX	Tape And Bandage, Adhesive	General Hospital	Class 1	880.5240	2022-07-23
KXF	Applicator, Absorbent Tipped, Non-Sterile	General Hospital	Class 1	880.6025	2022-07-23
MKY	System, Skin Closure	General, Plastic Surgery	Class 1	878.4320	2022-07-23
GLE	Mixer, Blood Tube	Clinical Chemistry	Class 1	862.2050	2022-07-23
FZZ	Marker, Skin	General, Plastic Surgery	Class 1	878.4660	2022-07-23
BYG	Mask, Oxygen	Anesthesiology	Class 1	868.5580	2022-07-23
IOY	Support, Arm	Physical Medicine	Class 1	890.3475	2022-07-23
HMP	Pad, Eye	General, Plastic Surgery	Class 1	878.4440	2022-07-23
FMH	Container, Specimen, Sterile	Pathology	Class 1	864.3250	2022-07-23
EXE	Protector, Ostomy	Gastroenterology, Urology	Class 1	876.5900	2022-07-23
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	2022-07-23
IQK	Orthosis, Cervical	Physical Medicine	Class 1	890.3490	2022-07-23
EZQ	Pouch, Colostomy	Gastroenterology, Urology	Class 1	876.5900	2022-07-23
EFN	Cotton, Roll	Dental	Class 1	872.6050	2022-07-23
HXT	Tape, Orthopedic	General, Plastic Surgery	Class 1	878.4800	2022-07-23
HTD	Forceps	General, Plastic Surgery	Class 1	878.4800	2022-07-23
KEW	Slides, Microscope	Pathology	Class 1	864.3010	2022-07-23
ILH	Splint, Hand, And Components	Physical Medicine	Class 1	890.3475	2022-07-23
NAE	Dressing, Wound, Hydrogel Without Drug And/Or Biologic	General, Plastic Surgery	Class 1	878.4022	2022-07-23
IMD	Pack, Hot Or Cold, Disposable	Physical Medicine	Class 1	890.5710	2022-07-23
JOL	Catheter And Tip, Suction	General Hospital	Class 2	880.6740	2022-07-23
ITQ	Joint, Knee, External Brace	Physical Medicine	Class 1	890.3475	2022-07-23
KIZ	Dish, Tissue Culture	Hematology	Class 1	864.2240	2022-07-23
GHK	Centrifuge, Microsedimentation	Hematology	Class 1	864.5350	2022-07-23
FOB	Bedpan	General Hospital	Class 1	880.6730	2022-07-23
ILI	Sling, Arm	Physical Medicine	Class 1	890.3640	2022-07-23
KGB	Mask, Oxygen, Non-Rebreathing	Anesthesiology	Class 1	868.5570	2022-07-23
IWO	Apron, Protective	Radiology	Class 1	892.6500	2022-07-23
MDA	Elastomer, Silicone, For Scar Management	General, Plastic Surgery	Class 1	878.4025	2022-07-23
IQE	Orthosis, Lumbar	Physical Medicine	Class 1	890.3490	2022-07-23
NAD	Dressing, Wound, Occlusive	General, Plastic Surgery	Class 1	878.4020	2022-07-23
OHO	First Aid Kit Without Drug	General, Plastic Surgery	Class 1	878.4014	2022-07-23
FQL	Stocking, Medical Support (For General Medical Purposes)	General Hospital	Class 1	880.5780	2022-07-23
NAC	Dressing, Wound, Hydrophilic	General, Plastic Surgery	Class 1	878.4018	2022-07-23
KME	Bedding, Disposable, Medical	General Hospital	Class 1	880.6060	2022-07-23
NAB	Gauze / Sponge,Nonresorbable For External Use	General, Plastic Surgery	Class 1	878.4014	2022-07-23
HIB	Speculum, Vaginal, Nonmetal	Obstetrics/Gynecology	Class 2	884.4530	2022-07-23
BTQ	Airway, Nasopharyngeal	Anesthesiology	Class 1	868.5100	2022-07-23
OEA	Non-Surgical Gown	General, Plastic Surgery	Class 1	878.4040	2022-07-23
FAQ	Bag, Urine Collection, Leg, For External Use, Sterile	Gastroenterology, Urology	Class 1	876.5250	2022-07-23
ITG	Bandage, Cast	Physical Medicine	Class 1	890.3025	2022-07-23
FNP	Urinal	General Hospital	Class 1	880.6730	2022-07-23

Official Correspondent

James Gao

US Agent Details

Sam Shi Business: Medwin Inc. Email: MedwinInc@Aliyun.Com Phone: (626) 2651595

Related Public Records

Same Entity

ANJI SPENQ INDUSTRIAL 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
K790050	Stanford Professional Products	SPONGES, STANFORD STERILE LAP	1979-01-17
K823241	Kimberly-Clark Corp.	NEW FREEDOM THIN UNSCENTED MAXI PADS	1982-12-28
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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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-0007-2013	Invuity, Inc.	2	BriteField illuminated Suction Device; Model numbers 8Fr, 10Fr and 12Fr, Kit (included 8Fr, 10Fr and 12Fr and a sterilization tray. The Invuity Brite Field Illuminated Suction Device is intended to aspirate from the surgical site and to provide illumination from a high intensity light source.
Z-0013-2019	COVIDIEN LLC	1	Kerlix AMD Antimicrobial Bandage Roll, 6 Ply, 4-1/2 x 12.3 (11.4 cm x 3.7m), REF 3332 Product Usage- as both primary and secondary dressing containing PHMB (polyhexamethylene biguanide) to resist bacterial colonization within the dressing and bacterial penetration through the dressing.

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3016758972. Last updated year: 2026. Please use registration number 3016758972 when referencing this establishment in official correspondence.