FDA Registration
Active
🇨🇳 China
O-Mec 690 Series Laparoscopes
Reg #: 3011459664
·
FEI: 3011459664
·
Expires 2025
Products
1
Proprietary Names
1
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- QINGDAO O-MEC MEDICAL TECHNOLOGY CO., LTD.
- Registration Number
- 3011459664
- FEI Number
- 3011459664
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- No.100 Keyuanweisi Rd.
- City
- Qingdao Shandong
- Country
- CN
Regulatory Submissions
- 510(k) Number
- K201151
Owner / Operator
- Firm Name
- Qingdao O-Mec Medical Technology Co., Ltd.
- Operator Number
- 10048000
- Address
- No.100 Keyuanweisi Rd.
- City
- Qingdao
- State
- Shandong
- Postal Code
- 266100
- Country
- CN
- Correspondent
- Linda Cong
US Agent
- Business Name
- OMEC Medical NV Inc.
- Contact Name
- Claire Nippress
- Address
- 5690 Riggins Ct
- City
- Reno
- State
- NV
- ZIP
- 89502
- Country
- US
- [email protected]
- Phone
- 775 3606339
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Laparoscope, General & Plastic Surgery | GCJ | Class 2 | Gastroenterology, Urology | No | 2020-07-02 |
Proprietary Names
O-Mec 690 Series Laparoscopes
Establishment Types
Manufacture Medical Device