FDA Registration
Active
🇨🇳 China
ANJI SPENQ INDUSTRIAL CO., LTD.
Reg #: 3016758972
·
FEI: 3016758972
·
Expires 2026
Products
85
Proprietary Names
87
Establishment Types
2
Classifications
85
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Registration Details
- Registration Name
- ANJI SPENQ INDUSTRIAL CO., LTD.
- Registration Number
- 3016758972
- FEI Number
- 3016758972
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- F16,Building C, Anji Chamber of Commerce Mansion, No.99 Tianhuangping South Road, Anji County
- City
- Huzhou Zhejiang
- Country
- CN
Owner / Operator
- Firm Name
- ANJI SPENQ INDUSTRIAL CO., LTD.
- Operator Number
- 10085700
- Address
- F16,Building C, Anji Chamber of Commerce Mansion, No.99 Tianhuangping South Road, Anji County
- City
- Huzhou
- State
- Zhejiang
- Postal Code
- 313300
- Country
- CN
- Correspondent
- James Gao
US Agent
- Business Name
- Medwin Inc.
- Contact Name
- Sam Shi
- Address
- 364 W Lane Ave, Apt 821
- City
- Columbus
- State
- OH
- ZIP
- 43201
- Country
- US
- [email protected]
- Phone
- 626 2651595
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Device, Urine Flow Rate Measuring, Non-Electrical, Disposable | FFG | Class 2 | Gastroenterology, Urology | No | 2022-07-23 |
| Gauze/Sponge, Internal, X-Ray Detectable | GDY | Class 1 | General, Plastic Surgery | No | 2022-07-23 |
| Restraint, Wheelchair, Non-Protective | KID | Class 1 | Physical Medicine | No | 2022-07-23 |
| Orthosis, Lumbo-Sacral | IPY | Class 1 | Physical Medicine | No | 2022-07-23 |
| Catheters, Suction, Tracheobronchial | BSY | Class 1 | Anesthesiology | No | 2022-07-23 |
| Wound Dressing Kit | MCY | Class 2 | General Hospital | No | 2022-07-23 |
| Syringe, Irrigating (Non Dental) | KYZ | Class 1 | General Hospital | No | 2022-07-23 |
| Pad, Menstrual, Unscented | HHD | Class 1 | Obstetrics/Gynecology | No | 2022-07-23 |
| Container, Specimen, Non-Sterile | NNI | Class 1 | Pathology | No | 2022-07-23 |
| Orthosis, Cervical-Thoracic, Rigid | IQF | Class 1 | Physical Medicine | No | 2022-07-23 |
| Shield, Eye, Ophthalmic (Including Sunlamp Protective Eyewear And Post-Mydriatic Eyewear) | HOY | Class 1 | Ophthalmic | No | 2022-07-23 |
| Tube, Aspirating, Flexible, Connecting | BYY | Class 2 | General Hospital | No | 2022-07-23 |
| Disinfectant, Medical Devices | LRJ | Class 1 | General Hospital | No | 2022-07-23 |
| Depressor, Tongue, Non-Surgical | FMA | Class 1 | General Hospital | No | 2022-07-23 |
| Tourniquet, Nonpneumatic | GAX | Class 1 | General, Plastic Surgery | No | 2022-07-23 |
| Tube, Tissue Culture | KJG | Class 1 | Pathology | No | 2022-07-23 |
| Orthosis, Limb Brace | IQI | Class 1 | Physical Medicine | No | 2022-07-23 |
| Tape And Bandage, Adhesive | KGX | Class 1 | General Hospital | No | 2022-07-23 |
| Applicator, Absorbent Tipped, Non-Sterile | KXF | Class 1 | General Hospital | No | 2022-07-23 |
| System, Skin Closure | MKY | Class 1 | General, Plastic Surgery | No | 2022-07-23 |
| Mixer, Blood Tube | GLE | Class 1 | Clinical Chemistry | No | 2022-07-23 |
| Marker, Skin | FZZ | Class 1 | General, Plastic Surgery | No | 2022-07-23 |
| Mask, Oxygen | BYG | Class 1 | Anesthesiology | No | 2022-07-23 |
| Support, Arm | IOY | Class 1 | Physical Medicine | No | 2022-07-23 |
| Pad, Eye | HMP | Class 1 | General, Plastic Surgery | No | 2022-07-23 |
| Container, Specimen, Sterile | FMH | Class 1 | Pathology | No | 2022-07-23 |
| Protector, Ostomy | EXE | Class 1 | Gastroenterology, Urology | No | 2022-07-23 |
| Face Mask Within The Scope Of The Face Mask And Barrier Face Covering Enforcement Policy Or Face Mask Umbrella Eua | QKR | Class N | Unknown | No | 2022-07-23 |
| Orthosis, Cervical | IQK | Class 1 | Physical Medicine | No | 2022-07-23 |
| Pouch, Colostomy | EZQ | Class 1 | Gastroenterology, Urology | No | 2022-07-23 |
| Cotton, Roll | EFN | Class 1 | Dental | No | 2022-07-23 |
| Tape, Orthopedic | HXT | Class 1 | General, Plastic Surgery | No | 2022-07-23 |
| Forceps | HTD | Class 1 | General, Plastic Surgery | No | 2022-07-23 |
| Slides, Microscope | KEW | Class 1 | Pathology | No | 2022-07-23 |
| Splint, Hand, And Components | ILH | Class 1 | Physical Medicine | No | 2022-07-23 |
| Dressing, Wound, Hydrogel Without Drug And/Or Biologic | NAE | Class 1 | General, Plastic Surgery | No | 2022-07-23 |
| Pack, Hot Or Cold, Disposable | IMD | Class 1 | Physical Medicine | No | 2022-07-23 |
| Catheter And Tip, Suction | JOL | Class 2 | General Hospital | No | 2022-07-23 |
| Joint, Knee, External Brace | ITQ | Class 1 | Physical Medicine | No | 2022-07-23 |
| Dish, Tissue Culture | KIZ | Class 1 | Hematology | No | 2022-07-23 |
| Centrifuge, Microsedimentation | GHK | Class 1 | Hematology | No | 2022-07-23 |
| Bedpan | FOB | Class 1 | General Hospital | No | 2022-07-23 |
| Sling, Arm | ILI | Class 1 | Physical Medicine | No | 2022-07-23 |
| Mask, Oxygen, Non-Rebreathing | KGB | Class 1 | Anesthesiology | No | 2022-07-23 |
| Apron, Protective | IWO | Class 1 | Radiology | No | 2022-07-23 |
| Elastomer, Silicone, For Scar Management | MDA | Class 1 | General, Plastic Surgery | No | 2022-07-23 |
| Orthosis, Lumbar | IQE | Class 1 | Physical Medicine | No | 2022-07-23 |
| Dressing, Wound, Occlusive | NAD | Class 1 | General, Plastic Surgery | No | 2022-07-23 |
| First Aid Kit Without Drug | OHO | Class 1 | General, Plastic Surgery | No | 2022-07-23 |
| Stocking, Medical Support (For General Medical Purposes) | FQL | Class 1 | General Hospital | No | 2022-07-23 |
| Dressing, Wound, Hydrophilic | NAC | Class 1 | General, Plastic Surgery | No | 2022-07-23 |
| Bedding, Disposable, Medical | KME | Class 1 | General Hospital | No | 2022-07-23 |
| Gauze / Sponge,Nonresorbable For External Use | NAB | Class 1 | General, Plastic Surgery | No | 2022-07-23 |
| Speculum, Vaginal, Nonmetal | HIB | Class 2 | Obstetrics/Gynecology | No | 2022-07-23 |
| Airway, Nasopharyngeal | BTQ | Class 1 | Anesthesiology | No | 2022-07-23 |
| Non-Surgical Gown | OEA | Class 1 | General, Plastic Surgery | No | 2022-07-23 |
| Bag, Urine Collection, Leg, For External Use, Sterile | FAQ | Class 1 | Gastroenterology, Urology | No | 2022-07-23 |
| Bandage, Cast | ITG | Class 1 | Physical Medicine | No | 2022-07-23 |
| Urinal | FNP | Class 1 | General Hospital | No | 2022-07-23 |
| Bag, Ice | KYR | Class 1 | General Hospital | No | 2022-07-23 |
| Bag, Drainage, With Adhesive, Ostomy | FON | Class 1 | Gastroenterology, Urology | No | 2022-07-23 |
| Basin, Emesis | FNY | Class 1 | General Hospital | No | 2022-07-23 |
| Device, Occlusion, Umbilical | FOD | Class 1 | General Hospital | No | 2022-07-23 |
| Cap, Surgical | FYF | Class 1 | General, Plastic Surgery | No | 2022-07-23 |
| Collector, Urine, Pediatric, For Indwelling Catheter | FFH | Class 2 | Gastroenterology, Urology | No | 2022-07-23 |
| Pipette, Pasteur | GJW | Class 1 | Hematology | No | 2022-07-23 |
| Centrifuges (Micro, Ultra, Refrigerated) For Clinical Use | JQC | Class 1 | Clinical Chemistry | No | 2022-07-23 |
| Micro Pipette | JRC | Class 1 | Clinical Chemistry | No | 2022-07-23 |
| Absorber, Saliva, Paper | KHR | Class 1 | Dental | No | 2022-07-23 |
| Coverslips, Microscope Slide | KES | Class 1 | Pathology | No | 2022-07-23 |
| Garment, Protective, For Incontinence | EYQ | Class 1 | Gastroenterology, Urology | No | 2022-07-23 |
| Mask, Oxygen, Low Concentration, Venturi | BYF | Class 1 | Anesthesiology | No | 2022-07-23 |
| Device, Intravascular Catheter Securement | KMK | Class 1 | General Hospital | No | 2022-07-23 |
| Cannula, Nasal, Oxygen | CAT | Class 1 | Anesthesiology | No | 2022-07-23 |
| Gown, Examination | FME | Class 1 | General Hospital | No | 2022-07-23 |
| Orthosis, Truncal/Orthosis, Limb | MRI | Class 1 | Physical Medicine | No | 2022-07-23 |
| Bandage, Elastic | FQM | Class 1 | General Hospital | No | 2022-07-22 |
| Joint, Ankle, External Brace | ITW | Class 1 | Physical Medicine | No | 2022-07-23 |
| Cover, Shoe, Operating-Room | FXP | Class 1 | General, Plastic Surgery | No | 2022-07-23 |
| Nebulizer, Medicinal, Non-Ventilatory (Atomizer) | CCQ | Class 1 | Anesthesiology | No | 2022-07-23 |
| Shield, Protective, Personnel | KPY | Class 1 | Radiology | No | 2022-07-23 |
| Nursing Pad, Polyurethane Pad With Starch Copolymer, Glycerin, And Surfactant (F-68) | NTX | Class 1 | General Hospital | No | 2022-07-23 |
| Mask, Gas, Anesthetic | BSJ | Class 1 | Anesthesiology | No | 2022-07-23 |
| Needle, Dental | DZM | Class 1 | Dental | No | 2022-07-23 |
| Mouthpiece, Saliva Ejector | DYN | Class 1 | Dental | No | 2022-07-23 |
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
ICE BAG
Ostomy Bag
Basin, Emesis
UMBILICAL Cord CLAMP
Nurse Cap, Doctor Cap, Surgical Cap,Bouffant Cap,Clip Cap
COLLECTOR, URINE, PEDIATRIC, FOR INDWELLING CATHETER
PIPETTE, PASTEUR
Micro Pipette
DENTAL BIBS
COVERSLIPS,MICROSCOPE SLIDE
Adult Diaper,Baby Diaper,Pet Diaper,Pull-Up Diaper
Adjustable Mask; Venturi Mask
Film Dressing, I.V. DRESSING
Nasal Oxygen Cannula
Surgeon Gown,Exam Gown
ORTHOSIS, TRUNCAL/ORTHOSIS, LIMB
Elastic Bandage,Tubular Bandage
JOINT, ANKLE, EXTERNAL BRACE
Shoe Cover,Boot Cover, Sleeve Cover
NEBULIZER, MEDICINAL, NON-VENTILATORY (ATOMIZER)
Face Shield
Underpad,Pet Pad,Nursing Pad
Anesthesia Mask
Dental Needle
SALIVA EJECTOR
Establishment Types
Export Device to the United States But Perform No Other Operation on Device
Manufacture Medical Device