FDA Registration
Active
🇨🇳 China
DONGGUAN SUPERCARE MEDICAL PRODUCTS CO., LTD
Reg #: 3013657868
·
FEI: 3013657868
·
Expires 2026
Products
41
Proprietary Names
44
Establishment Types
3
Classifications
41
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Registration Details
- Registration Name
- DONGGUAN SUPERCARE MEDICAL PRODUCTS CO., LTD
- Registration Number
- 3013657868
- FEI Number
- 3013657868
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- NO. 22 QULING 2ND ROAD, QUANTANG, LIAOBU TOWN
- City
- Dongguan Guangdong
- Country
- CN
Owner / Operator
- Firm Name
- DONGGUAN SUPERCARE MEDICAL PRODUCTS CO., LTD
- Operator Number
- 10056657
- Address
- NO. 22 QULING 2ND ROAD, QUANTANG, LIAOBU TOWN
- City
- Dongguan
- State
- Guangdong
- Postal Code
- 523418
- Country
- CN
- Correspondent
- ROCK WANG
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 |
|---|---|---|---|---|---|
| Insoles, Medical | KYS | Class 1 | General Hospital | No | 2020-06-17 |
| Crutch | IPR | Class 1 | Physical Medicine | No | 2017-12-30 |
| Orthosis, Cervical-Thoracic, Rigid | IQF | Class 1 | Physical Medicine | No | 2020-06-16 |
| Tape And Bandage, Adhesive | KGX | Class 1 | General Hospital | No | 2020-06-16 |
| Orthosis, Lumbo-Sacral | IPY | Class 1 | Physical Medicine | No | 2017-12-30 |
| Orthosis, Limb Brace | IQI | Class 1 | Physical Medicine | No | 2020-06-06 |
| Orthosis, Cervical | IQK | Class 1 | Physical Medicine | No | 2017-12-30 |
| Joint, Knee, External Brace | ITQ | Class 1 | Physical Medicine | No | 2017-12-30 |
| Orthosis, Rib Fracture, Soft | IPX | Class 1 | Physical Medicine | No | 2020-06-16 |
| Stocking, Elastic | ILG | Class 1 | Physical Medicine | No | 2017-12-30 |
| Bandage, Elastic | FQM | Class 1 | General Hospital | No | 2020-06-16 |
| Splint, Extremity, Non-Inflatable, External, Non-Sterile | NOC | Class 1 | General, Plastic Surgery | No | 2017-12-30 |
| Orthosis, Corrective Shoe | KNP | Class 1 | Physical Medicine | No | 2017-12-30 |
| Binder, Abdominal | FSD | Class 1 | General Hospital | No | 2017-12-30 |
| Cage, Knee | ITM | Class 1 | Physical Medicine | No | 2020-06-16 |
| Joint, Ankle, External Brace | ITW | Class 1 | Physical Medicine | No | 2017-12-30 |
| Joint, Hip, External Brace | ITS | Class 1 | Physical Medicine | No | 2020-06-13 |
| Splint, Abduction, Congenital Hip Dislocation | IOZ | Class 1 | Physical Medicine | No | 2020-06-16 |
| Band Or Belt, Pelvic Support | ISR | Class 1 | Physical Medicine | No | 2017-12-30 |
| Support, Hernia | EXN | Class 1 | Gastroenterology, Urology | No | 2017-12-30 |
| Support, Arm | IOY | Class 1 | Physical Medicine | No | 2018-01-10 |
| Orthosis, Foot Drop | OHI | Class 1 | Physical Medicine | No | 2020-06-17 |
| Orthosis, Lumbar | IQE | Class 1 | Physical Medicine | No | 2019-05-20 |
| Accessory, Surgical Apparel | LYU | Class 1 | General, Plastic Surgery | No | 2020-03-30 |
| Joint, Knee, External Limb Component | ISY | Class 1 | Physical Medicine | No | 2022-11-21 |
| Orthosis, Abdominal | KTD | Class 1 | Physical Medicine | No | 2020-06-16 |
| Orthosis, Truncal/Orthosis, Limb | MRI | Class 1 | Physical Medicine | No | 2020-06-06 |
| Unit, Wrist, External Limb Component, Mechanical | ISZ | Class 1 | Physical Medicine | No | 2020-06-17 |
| Orthosis, Sacroiliac, Soft | IPW | Class 1 | Physical Medicine | No | 2020-06-17 |
| Splint, Hand, And Components | ILH | Class 1 | Physical Medicine | No | 2018-01-10 |
| Bag, Ice | KYR | Class 1 | General Hospital | No | 2017-12-30 |
| 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 | 2020-03-30 |
| Shoe, Cast | IPG | Class 1 | Physical Medicine | No | 2020-06-16 |
| Pack, Hot Or Cold, Reusable | IME | Class 1 | Physical Medicine | No | 2017-12-30 |
| Splint, Clavicle | IQJ | Class 1 | Physical Medicine | No | 2017-12-30 |
| Joint, Elbow, External Limb Component, Mechanical | IRD | Class 1 | Physical Medicine | No | 2020-06-17 |
| Binder, Perineal | FQK | Class 1 | General Hospital | No | 2020-06-17 |
| Protector, Skin Pressure | FMP | Class 1 | General Hospital | No | 2017-12-30 |
| Sling, Arm | ILI | Class 1 | Physical Medicine | No | 2017-12-30 |
| Joint, Shoulder, External Limb Component | IQQ | Class 1 | Physical Medicine | No | 2017-12-30 |
| Support, Scrotal, Therapeutic | FQJ | Class 1 | General Hospital | No | 2020-06-17 |
Proprietary Names
Silicone insole, Silicone Heel Cup
CAM WALKER ,CRUTCH
ORTHOSIS, CERVICAL-THORACIC, RIGID
TAPE AND BANDAGE, ADHESIVE
ORTHOSIS, LUMBO- SACRAL
Orthosis
Limb Brace
CERVICAL COLLARS
Knee support
HEAD HALTER
ORTHOSIS, RIB FRACTURE,Rib Belt
THIGH SUPPORT
CALF SUPPORT
calf extender
ATHLETIC TAPE
FINGER SPLINTS
ORTHOSIS,CORRECTIVE SHOE
ABDOMINAL BINDER
FUNCTIONAL KNEE BRACE
ANKLE BRACE,JOINT,ANKLE,EXTERANL BRACE
HIP ABDUCTION KIT
BACK SUPPORT
HERINA BELT
ELBOW SUPPORTS
Orthosis, Foot Drop
Orthosis, lumbar, complete panel
disposable mask, face mask
Joint, Knee, External Limb Component
ABDOMINAL SUPPORTS
Orthosis Limb
Orthosis Truncal
Unit, Wrist, External Limb Component, Mechanical
ORTHOSIS, SACROILIAC, SOFT
WRIST BRACE, HAND SUPPORT
BAG, ICE
SHOE, CAST
Pack, hot or cold, reuseable
CLAVICLE SUPPORT
OINT, ELBOW, EXTERNAL LIMB COMPONENT
BINDER, PERINEAL
Protector,skin pressure
ARM SLINGS
SHOULDER SUPPORTS
SUPPORT, SCROTAL
Establishment Types
Export Device to the United States But Perform No Other Operation on Device
Manufacture Medical Device
Manufacture Medical Device for Another Party (Contract Manufacturer)