FDA Registration
Active
🇨🇳 China
Suzhou Colour-way New Material Co., Ltd.
Reg #: 3008062466
·
FEI: 3008062466
·
Expires 2026
Products
5
Proprietary Names
8
Establishment Types
1
Classifications
5
Registration Details
- Registration Name
- Suzhou Colour-way New Material Co., Ltd.
- Registration Number
- 3008062466
- FEI Number
- 3008062466
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- No. 20, Anmin Road, Huangdai Town, Xiangcheng District
- City
- Suzhou Jiangsu
- Country
- CN
Regulatory Submissions
- 510(k) Number
- K222620
Owner / Operator
- Firm Name
- Suzhou Colour-way New Material Co., Ltd.
- Operator Number
- 10030755
- Address
- No. 20, Anmin Road, Huangdai Town, Xiangcheng District
- City
- Suzhou
- State
- Jiangsu
- Postal Code
- 215152
- Country
- CN
- Correspondent
- Lingling Yu
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 |
|---|---|---|---|---|---|
| Surgeon'S Gloves | KGO | Class 1 | General, Plastic Surgery | No | 2023-04-07 |
| Apron, Protective | IWO | Class 1 | Radiology | No | 2023-04-13 |
| Shield, Protective, Personnel | KPY | Class 1 | Radiology | No | 2023-12-13 |
| Condom | HIS | Class 2 | Obstetrics/Gynecology | No | 2009-11-08 |
| Radiographic Protective Glove | IWP | Class 1 | Radiology | No | 2018-10-09 |
Proprietary Names
Sterilized Latex Surgical Gloves
Radiation protection cap, Thyroid collar
Radiation protection sleeve
Jass Duro, m. Dior, S Shock Shark Condoms
Jass Duro, Male Latex Condoms
Powdered Latex Surgeon's Glove
Radiation Protection Gloves
Polyisoprene Surgical gloves
Establishment Types
Manufacture Medical Device