FDA Registration
Active
🇨🇳 China
StepOne Ltd
Reg #: 3013756293
·
FEI: 3013756293
·
Expires 2025
Products
1
Proprietary Names
1
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- IMMETECH INDUSTRIAL CO.,LTD
- Registration Number
- 3013756293
- FEI Number
- 3013756293
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- Building 6, Huixin Industrial Park, Daxing Rd, Yangwu, Dalingshan Town
- City
- Dongguan City Guangdong
- Country
- CN
Regulatory Submissions
- 510(k) Number
- K242031
Owner / Operator
- Firm Name
- IMMETECH INDUSTRIAL CO.,LTD
- Operator Number
- 10092065
- Address
- Building 6, Huixin Industrial Park, Daxing Rd, Yangwu, Dalingshan Town
- City
- Dongguan City
- State
- Guangdong
- Postal Code
- 523839
- Country
- CN
- Correspondent
- Alexandra C Le Sueur
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Kit, Conception-Assist, Home Use | OBB | Class 2 | Obstetrics/Gynecology | No | 2025-06-23 |
Proprietary Names
StepOne Ltd
Establishment Types
Manufacture Medical Device for Another Party (Contract Manufacturer)