FDA Registration
Active
🇹🇭 Thailand
OMEC THAI CO.,LTD.
Reg #: 3033902430
·
FEI: 3033902430
·
Expires 2026
Products
4
Proprietary Names
21
Establishment Types
1
Classifications
4
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Registration Details
- Registration Name
- OMEC THAI CO.,LTD.
- Registration Number
- 3033902430
- FEI Number
- 3033902430
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- 111/11, Mu 4, Khlong Suan Sub-district
- City
- Bang Bo District Samut Prakan
- Country
- TH
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
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| 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 | 2022-07-07 |
Proprietary Names
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
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
Establishment Types
Manufacture Medical Device for Another Party (Contract Manufacturer)