FDA Registration
Active
🇨🇳 China
Suzhou Armocon Technology Co., Ltd.
Reg #: 3007962592
·
FEI: 3007962592
·
Expires 2026
Products
4
Proprietary Names
2
Establishment Types
2
Classifications
4
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Registration Details
- Registration Name
- Suzhou Armocon Technology Co., Ltd.
- Registration Number
- 3007962592
- FEI Number
- 3007962592
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- 3-5/F, No.77,Suhong Middle Road, Suzhou Industrial Park
- City
- Jiangsu
- Country
- CN
Regulatory Submissions
- 510(k) Number
- K140780
Owner / Operator
- Firm Name
- Sedic
- Operator Number
- 10036125
- Address
- 5799 Fontanoso Way
- City
- San Jose
- State
- CA
- Postal Code
- 95138
- Country
- US
- Correspondent
- Pavle Sedic
US Agent
- Business Name
- LELO, INC.
- Contact Name
- Pavle Sedic
- Address
- 5799 Fontanoso Way
- City
- San Jose
- State
- CA
- ZIP
- 95138
- Country
- US
- [email protected]
- Phone
- 408 2494000
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Device, External Penile Rigidity | LKY | Class 2 | Gastroenterology, Urology | No | 2012-10-13 |
| Massager, Therapeutic, Electric | ISA | Class 1 | Physical Medicine | No | 2011-04-20 |
| Perineometer | HIR | Class 2 | Obstetrics/Gynecology | No | 2014-09-24 |
| Cup, Menstrual | HHE | Class 2 | Obstetrics/Gynecology | No | 2014-09-24 |
Proprietary Names
Ziggy Cup
Lily Cup One
Establishment Types
Complaint File Establishment per 21 CFR 820.198
Manufacture Medical Device