FDA Registration
Active
🇨🇳 China
CHANGZHOU RECOO HEALTHCARE CO., LTD.
Reg #: 3010805190
·
FEI: 3010805190
·
Expires 2026
Products
19
Proprietary Names
23
Establishment Types
3
Classifications
19
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Registration Details
- Registration Name
- CHANGZHOU RECOO HEALTHCARE CO., LTD.
- Registration Number
- 3010805190
- FEI Number
- 3010805190
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- 402 No3 BLD ZHIYAN Valley BOJI Industrial Zone Zouqu Town Zhonglou
- City
- Changzhou Jiangsu
- Country
- CN
Owner / Operator
- Firm Name
- Changzhou Recoo Healthcare Co., Ltd.
- Operator Number
- 10046329
- Address
- 402 No3 BLD ZHIYAN Valley BOJI Industrial Zone Zouqu Town Zhonglou
- City
- Changzhou
- State
- Jiangsu
- Postal Code
- 213000
- Country
- CN
- Correspondent
- Sherlock Zhou
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 |
|---|---|---|---|---|---|
| Pack, Hot Or Cold, Reusable | IME | Class 1 | Physical Medicine | No | 2015-12-17 |
| Dressing, Wound, Hydrophilic | NAC | Class 1 | General, Plastic Surgery | No | 2020-10-23 |
| Bedding, Disposable, Medical | KME | Class 1 | General Hospital | No | 2015-12-17 |
| Bag, Ice | KYR | Class 1 | General Hospital | No | 2015-12-17 |
| Dilator, Nasal | LWF | Class 1 | Ear, Nose, Throat | No | 2023-11-07 |
| Marker, Skin | FZZ | Class 1 | General, Plastic Surgery | No | 2019-12-05 |
| 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 | 2020-06-28 |
| First Aid Kit Without Drug | OHO | Class 1 | General, Plastic Surgery | No | 2017-11-06 |
| Tourniquet, Nonpneumatic | GAX | Class 1 | General, Plastic Surgery | No | 2024-10-21 |
| Scale, Surgical Sponge | FQA | Class 1 | General Hospital | No | 2024-10-21 |
| Dressing, Wound, Occlusive | NAD | Class 1 | General, Plastic Surgery | No | 2021-10-24 |
| Elastomer, Silicone, For Scar Management | MDA | Class 1 | General, Plastic Surgery | No | 2022-08-15 |
| Mask, Oxygen | BYG | Class 1 | Anesthesiology | No | 2015-12-17 |
| Protector, Hearing (Insert) | EWD | Class U | Unknown | No | 2023-11-07 |
| Bandage, Elastic | FQM | Class 1 | General Hospital | No | 2014-03-06 |
| Pad, Alcohol, Device Disinfectant | LKB | Class U | Unknown | No | 2016-07-09 |
| Bag, Urine Collection, Leg, For External Use, Non-Sterile | NNW | Class 1 | Gastroenterology, Urology | No | 2017-11-12 |
| Tape And Bandage, Adhesive | KGX | Class 1 | General Hospital | No | 2015-12-17 |
| Garment, Protective, For Incontinence | EYQ | Class 1 | Gastroenterology, Urology | No | 2015-12-17 |
Proprietary Names
Hot and cold pack
Sterile hydrocolloid dressing, FOOT BLISTER PAD /FOOT CUSHION, ACNE PATCH/PIMPLE PATCH
Under pad
Ice Pack
Nasal Strip
Identification Band
Medical Face Mask
First aid kit without drug
Tourniquet
Latex bandage, Elastic bandage
Wound dressing series
Silicone Scar Tape, SILICONE TAPE/SILICONE SCAR SHEET
Oxygen mask
Nebulizer mask
Ear Plug
Kinesiology Tape
Foam Tape
Sports Tape
Alcohol pad
Urine bag
EYE PATCH
Cohesive Bandage, Wound adhesive bandage, Zinc Oxide Adhesive Plaster, Surgical Tape, Adhesive Patch, Hostage tape,
Diaper
Establishment Types
Manufacture Medical Device for Another Party (Contract Manufacturer)
Export Device to the United States But Perform No Other Operation on Device
Manufacture Medical Device