FDA Registration
Active
🇨🇳 China
OCEAN WELL CO., LTD.
Reg #: 3007125287
·
FEI: 3007125287
·
Expires 2026
Products
5
Proprietary Names
6
Establishment Types
2
Classifications
5
Registration Details
- Registration Name
- OCEAN WELL CO., LTD.
- Registration Number
- 3007125287
- FEI Number
- 3007125287
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- Rm. 201, Building 1, No. 38, Baihao Industry St., Houjie Town,, Dongguan City, Guangdong, China
- City
- Dongguan Guangdong
- Country
- CN
Owner / Operator
- Firm Name
- Ocean Well Co., Ltd.
- Operator Number
- 10026765
- Address
- Rm. 201, Building 1, No. 38, Baihao Industry St., Houjie town,
- City
- Dongguan
- State
- Guangdong
- Postal Code
- 523955
- Country
- CN
- Correspondent
- James Chang
US Agent
- Business Name
- Darco International Inc.
- Contact Name
- Mark Cooper
- Address
- 810 Memorial Blvd. Huntington
- City
- Huntington
- State
- WV
- ZIP
- 25701
- Country
- US
- [email protected]
- Phone
- 304 5224883
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Orthosis, Corrective Shoe | KNP | Class 1 | Physical Medicine | No | 2009-02-12 |
| Protector, Skin Pressure | FMP | Class 1 | General Hospital | No | 2017-04-12 |
| Stocking, Medical Support (For General Medical Purposes) | FQL | Class 1 | General Hospital | No | 2017-08-31 |
| Joint, Ankle, External Brace | ITW | Class 1 | Physical Medicine | No | 2017-04-12 |
| Shoe, Cast | IPG | Class 1 | Physical Medicine | No | 2008-08-20 |
Proprietary Names
ORTHOTIC APPLIANCE- POST OPERATIVE SHOE
Protector, skin pressure
FQL - STOCKING, MEDICAL SUPPORT (FOR GENERAL MEDICAL PURPOSES)
JOINT, ANKLE, EXTERNAL BRACE
Slimline Cast Boot
Poly Cast Boot, Law Profile Cast Shoe
Establishment Types
Manufacture Medical Device
Manufacture Medical Device for Another Party (Contract Manufacturer)