FDA Registration
Active
🇨🇳 China
HENGSHUI GANGSHENG MEDICAL INSTRUMENTS CO., LTD
Reg #: 3013856565
·
FEI: 3013856565
·
Expires 2026
Products
35
Proprietary Names
74
Establishment Types
3
Classifications
35
Registration Details
- Registration Name
- HENGSHUI GANGSHENG MEDICAL INSTRUMENTS CO., LTD
- Registration Number
- 3013856565
- FEI Number
- 3013856565
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- 1000 meters South of Dadi Town Government, Dadi village, Dadi Town, Shenzhou City
- City
- Hengshui Hebei
- Country
- CN
Owner / Operator
- Firm Name
- Hengshui Gangsheng Medical Instruments Co., Ltd
- Operator Number
- 10056289
- Address
- 1000 meters South of Dadi Town Government, Dadi village, Dadi Town, Shenzhou City
- City
- Hengshui
- State
- Hebei
- Postal Code
- 053800
- Country
- CN
- Correspondent
- XinYing Liu
US Agent
- Business Name
- Regrek LLC
- Contact Name
- Leeyeo Kee
- Address
- 19 Holly Cove Ln.,
- City
- Dover
- State
- DE
- ZIP
- 19901
- Country
- US
- [email protected]
- Phone
- 302 6089028
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Device, Transfer, Patient, Manual | FMR | Class 1 | General Hospital | No | 2017-11-25 |
| Joint, Knee, External Brace | ITQ | Class 1 | Physical Medicine | No | 2017-11-25 |
| Orthosis, Rib Fracture, Soft | IPX | Class 1 | Physical Medicine | No | 2017-11-25 |
| Orthosis, Lumbar | IQE | Class 1 | Physical Medicine | No | 2023-01-05 |
| Joint, Elbow, External Limb Component, Mechanical | IRD | Class 1 | Physical Medicine | No | 2023-11-09 |
| 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 | 2020-04-22 |
| Splint, Hand, And Components | ILH | Class 1 | Physical Medicine | No | 2023-11-09 |
| Orthosis, Corrective Shoe | KNP | Class 1 | Physical Medicine | No | 2023-01-05 |
| Orthosis, Limb Brace | IQI | Class 1 | Physical Medicine | No | 2023-11-09 |
| Splint, Extremity, Non-Inflatable, External, Non-Sterile | NOC | Class 1 | General, Plastic Surgery | No | 2017-11-25 |
| Joint, Shoulder, External Limb Component | IQQ | Class 1 | Physical Medicine | No | 2023-11-09 |
| Splint, Abduction, Congenital Hip Dislocation | IOZ | Class 1 | Physical Medicine | No | 2023-11-09 |
| Non-Surgical Gown | OEA | Class 1 | General, Plastic Surgery | No | 2020-04-22 |
| Tourniquet, Nonpneumatic | GAX | Class 1 | General, Plastic Surgery | No | 2017-11-25 |
| Unit, Wrist, External Limb Component, Mechanical | ISZ | Class 1 | Physical Medicine | No | 2023-11-09 |
| Walker, Mechanical | ITJ | Class 1 | Physical Medicine | No | 2017-11-25 |
| Radiographic Protective Glove | IWP | Class 1 | Radiology | No | 2020-04-22 |
| Pad, Heating, Powered | IRT | Class 2 | Physical Medicine | No | 2025-12-09 |
| Assembly, Shoulder/Elbow/Forearm/Wrist/Hand, Mechanical | KFT | Class 1 | Physical Medicine | No | 2023-11-09 |
| Cane | IPS | Class 1 | Physical Medicine | No | 2017-11-25 |
| Bandage, Elastic | FQM | Class 1 | General Hospital | No | 2017-11-25 |
| Stretcher, Wheeled | FPO | Class 2 | General Hospital | No | 2024-12-12 |
| Support, Hernia | EXN | Class 1 | Gastroenterology, Urology | No | 2020-12-29 |
| Sling, Arm | ILI | Class 1 | Physical Medicine | No | 2021-11-10 |
| Support, Arm | IOY | Class 1 | Physical Medicine | No | 2023-11-09 |
| Orthosis, Truncal/Orthosis, Limb | MRI | Class 1 | Physical Medicine | No | 2023-11-09 |
| Mouthpiece, Breathing | BYP | Class 1 | Anesthesiology | No | 2023-11-09 |
| Orthosis, Foot Drop | OHI | Class 1 | Physical Medicine | No | 2023-11-09 |
| Restraint, Protective | FMQ | Class 1 | General Hospital | No | 2021-11-10 |
| Orthosis, Cervical | IQK | Class 1 | Physical Medicine | No | 2017-11-25 |
| Crutch | IPR | Class 1 | Physical Medicine | No | 2017-11-25 |
| Joint, Ankle, External Brace | ITW | Class 1 | Physical Medicine | No | 2017-11-25 |
| Pack, Heat, Moist | IMA | Class 1 | Physical Medicine | No | 2025-12-09 |
| Band Or Belt, Pelvic Support | ISR | Class 1 | Physical Medicine | No | 2017-11-25 |
| Accessory, Surgical Apparel | LYU | Class 1 | General, Plastic Surgery | No | 2020-04-22 |
Proprietary Names
Air mattress
Externa - Ankle Brace With Air Bag
Knee Protector (knitted); Knee Protector (Sport); Inflatable Ankle Support Inflatable,
Knee Brace; Knee Support; Knee Protector; Knee sleeve; Knee lmmobilizer; Knee Wrap;
Hinged Knee Support Enhanced Knee Brace; OA Knee Brace: Rom Knee Support: Leg Protector: Patella Strap;
Patella Support: Patella Open Knee Brace: Adjustable knee Brace: leg Knee Support Sport knee Protector:
Orthopedic Orthosis, Rib Fracture, Rib Belt, Prosthetic Suspension Belt
Medical Elastic Lumbostad Corset; Waist Brace; Waist Support; Waist Protector; Waist Protector
Lumbar Brace; Drawstring Lumbar Brace; Lumbar Extender; Lumbar Protector; Lumbar Support;
Elbow Support, Elbow Brace
Face shield
Mask
Protective face shield
Long Thumb Spica; Thumb Brace; Palm Protector: Distal Metacarpal Brace
Fist Metacarpal Brace: Middle Metacarpal Brace; Proximal Metacarpal Bone Brace; Short Thumb Spica;
Wrist Splint; Palm Splint; Palm Support; Palm Brace; Finger Splint; Hand Finger Splint; Hinged Infusion Splint;
Walker Boot
Wrist Splint; Wrist Wrap; Hand Support; Thumb Support; Thumb Stabilizer Braces; Toe Brace/Protector:
Hallux Valgus Brace: Knee Brace: Knee Ankle Foot Orthosis; Leg Brace; Leg Protector; Calf Support; Hip Joint Brace;
Hip Resistance Bands; Thigh Support; Thigh Trimmer; Toe Brace: Teo Protector: Hallux Valgus Brace: Waist Brace:
Waist Support; Arm Trimmer
Elbow Brace: Elbow Support; Shoulder Abduction Brace; Shoulder Support; Rom Shoulder Brace; Wrist Brace; Wrist Support;
Inflatable Emergency Splint: Roll Type Splint; Night Splint; Medical Splint
Shoulder brace, Shoulder pad, Shoulder wrap
Hip joint orthosis, Hip support, Hip brace, Hip knee support
Disposable isolation gown
tourniquet
Wrist Brace: Wrist Support; Adjustable Wrist Brace; Night Wrist Support (Palm Wrist Brace); Wrist Protector
Walker, Rollator, Walking Aid
Disposable gloves
Electric Over Blanket; Far Infrared Heating Pad; Foot Warming Pad; Heat Therapy Knee Wrap; Heated Ankle Support Brace;
Pad, Heating, Powered(Back Recovery Wrap; Electric Foot Warmer; Electric Heating Jacket; Electric Heating Pad;
Heating Hand Pad; Heating Jacket; Heating Knee; Heating Knee Brace; Heating Knee Pad; Heating Kneepad; Heating Pad;
Heating Pad for Abdomen Period Pain Relief; Heating Pad for Neck and Shoulders; Heating Pad Wrap; Heating Shoulder Pad;
Heated Shoulder Wrap; Heated Socks; Heated Therapy Elbow Wrap; Heated Vest; Heated Waist Support Belt; Heated Wrap;
Heated/Heating Shoulder Support; Heating Belt; Heating Blanket; Heating Eye Mask; Heating Foot Pad; Heating Gloves;
Infrared Light Heating Knee Pad; Infrared Light Heating Wrist Brace; Infrared Light Heating Wrist Brace;
Heating Slippers; Heating Vest; Heating Waist Belt; Heating Waist Wrap; Heating Wrist Brace;
Heated Back Cushion; Heated Belt; Heated Cervical Pillow; Heated Gloves; Heated Jacket; Heated Kneepad; Heated Pad;
Infrared Light Therapy Belt; Neck and Shoulder Heating Pad; Powered Heating Pa)
Wrist support, Elbow Brace; Wrist Brace; Palm Guard
Hand crutch
Bandage, Elastic bandage, Elastic Crepe Bandage, Gauze Bandage (Gauze Rol), Mesh Bandage
Cervical Traction Belt, Neck Stretcher Hammock, Neck Stretching Fixation Belt,
Neck Stretcher Cervical Neck Traction Device, Cervical Neck Traction Device, Neck Cone Traction, Neck Hanging
Hernia Belt Support
Sling, Arm - Arm Sling
Arm Abduction, Shoulder Abduction, Arm Shoulder Abduction Brace, Shoulder Sling (Forearm sling)
Tennis Elbow Support: Elbow Brace: Adjustable Elbow race: Arm Band Elbow Protector; Elbow Sleeve; Arm Support,
Back Posture Corrector; Back Support Belt; Shoulder Brace; Clavicle Brace; Upper Back Clavicle Brace; Body Pillow; TLSO
Back Posture 0rthosis: Back Support; Back Brace; Posture Corrector: Adjustable Posture Corrector;
Snore Stoppers, Stop Snore Mouthguard
Medical Shoe, Surgical Shoe)
Foot Drop Splint, Night splint: Dorsal Night Splint: Foot drop brace; Below Knee Orthosis (BKO);
Foot Pad: Arch Support Cushion/Arch Support Pad; Toe Separator, Toe Cap, Toe Protector, Toe Corrector, Bunion Protector,
Ankle Foot Orthosis (AFO); AFO; Adjustable Foot Drop Brace; Foot Brace Shoe; Dual Foot Stretcher; Foot Stretcher;
Toe Straightener, Toe Splint, Bunion Corrector, Post-op Shoe (Post - Operative Shoe, Post OP Shoe, Postoperative Shoe,
Resistance Bands, Limb holder, Wheelchair Seatbelt, Wheelchair Seat Belt, Wheelchair Safety Belt,
Wheelchair Leg Restraints Strap
Cervical collar,Foam neck brace,Philadelphia Cervical Collar,Inflatable cervical collar,Adjustable cervical collar
Orthosis, Cervical - Neck Traction
Walking Stick
Inflatable Ankle Support; Ankle Brace With Air Bag; Foot Splint Laced Ankle Brace; AFO Brace: Dorsal Night Splint;
Ankle Straps; Ankle Wraps; Ankle Walking Boots; Ankle Sleeve; Compression Ankle Sleeve; Arch Support; Foot Arch Support;
Hallux Valgus; Bunion Corrector
Ake Brace: Adjustable Ankle Foot Brace: Ankle Protector: Ankle Protector (Knitted): Ankle Protector (Sport):
HOT PACK (DISPOSABLE); HOT PACK REUSABLE; Heated Warm Glove Pack)
PACK, HEAT, MOIST (Moist Heating Pad, Multiple Sizes of Steam Packs; Lower Back Heat Wrap; Neck Heat Wrap;
Maternity Support; Maternity Support Belt; Maternity Belts; Pregnant Support Belt; Postpartum Belt; Postpartum support;
Waist Support Belts; Waist Trainer Belt; Ostomy belt
Postpartum Support Belt; Pelvic Support Belt; Postpartum Bely Band: Abdominal Support; Abdominal Binder;
Disposable hair cover
Disposable Protective clothing
Disposable boots
Establishment Types
Manufacture Medical Device
Manufacture Medical Device for Another Party (Contract Manufacturer)
Export Device to the United States But Perform No Other Operation on Device