FDA Registration
Active
🇨🇳 China
QINGDAO O-MEC MEDICAL TECHNOLOGY CO., LTD.
Reg #: 3011459664
·
FEI: 3011459664
·
Expires 2026
Products
6
Proprietary Names
24
Establishment Types
2
Classifications
6
Registration Details
- Registration Name
- QINGDAO O-MEC MEDICAL TECHNOLOGY CO., LTD.
- Registration Number
- 3011459664
- FEI Number
- 3011459664
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- No.100 Keyuanweisi Rd.
- City
- Qingdao Shandong
- Country
- CN
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 |
|---|---|---|---|---|---|
| Accessories, Photographic, For Endoscope (Exclude Light Sources) | FEM | Class 1 | Gastroenterology, Urology | No | 2014-11-24 |
| Cystoscope And Accessories, Flexible/Rigid | FAJ | Class 2 | Gastroenterology, Urology | No | 2024-02-13 |
| Endoscope, Accessories, Narrow Band Spectrum | NWB | Class 2 | Gastroenterology, Urology | No | 2024-02-13 |
| Hysteroscope (And Accessories) | HIH | Class 2 | Obstetrics/Gynecology | No | 2024-02-13 |
| Laparoscope, General & Plastic Surgery | GCJ | Class 2 | Gastroenterology, Urology | No | 2020-07-02 |
| Confocal Optical Imaging | OWN | Class 2 | Gastroenterology, Urology | No | 2015-03-19 |
Proprietary Names
C-Mount Right Angle Coupler
SPY Cystoscope/Hysteroscope, Autoclavable, Speed-Lock, 4 mm x 70°, 30 cm
SPY Cystoscope/Hysteroscope, Autoclavable, KS-Series, 4 mm x 70°, 30 cm
SPY Cystoscope/Hysteroscope, Autoclavable, KS-Series, 4 mm x 12°, 30 cm
O-Adapter, Speed-lock, Cystoscope
SPY Cystoscope/Hysteroscope, Autoclavable, Speed-Lock, 4 mm x 12°, 30 cm
SPY Cystoscope/Hysteroscope, Autoclavable, Speed-Lock, 4 mm x 0°, 30 cm
SPY Cystoscope/Hysteroscope, Autoclavable, KS-Series, 4 mm x 0°, 30 cm
SPY Cystoscope/Hysteroscope, Autoclavable, KS-Series, 4 mm x 30°, 30 cm
SPY Cystoscope/Hysteroscope, Autoclavable, Speed-Lock, 4 mm x 30°, 30 cm
O-Mec 690 Series Laparoscopes
SPY Laparoscope, Autoclavable, 5.4 mm x 30, 30cm
SPY Bariatric Laparoscope, Autoclavable, 5.4 mm x 30, 45cm
SPY Laparoscope, Autoclavable, 5.4 mm x 45, 30cm
SPY Bariatric Laparoscope, Autoclavable, 10mm x 30, 45cm
SPY Bariatric Laparoscope, Autoclavable, 5.4 mm x 45, 45cm
SPY Laparoscope, Autoclavable, 10mm x 30, 33cm
SPY Laparoscope, Autoclavable, 5.4 mm x 0, 30cm
SPY Laparoscope, Autoclavable, 10mm x 45, 33cm
SPY Bariatric Laparoscope, Autoclavable, 10mm x 45, 45cm
SPY Bariatric Laparoscope, Autoclavable, 5.4 mm x 0, 45cm
SPY Laparoscope, Autoclavable, 10mm x 0, 33cm
SPY Bariatric Laparoscope, Autoclavable, 10mm x 0, 45cm
IRF Laparoscope
Establishment Types
Manufacture Medical Device for Another Party (Contract Manufacturer)
Manufacture Medical Device